Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-29 @ 5:45 PM
Study NCT ID:
NCT03060551
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nasuko@catholic.ac.kr', 'phone': '821090803527', 'title': 'Suk-Ho Moon', 'organization': "Department of Plastic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 weeks', 'description': 'No serious adverse events occurred throughout study.', 'eventGroups': [{'id': 'EG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment. All patients were regulary assessed at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Transient paresthesia in liposuction lesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness after lidocaine injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Transient pallor in finger after injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Raynaud's Condition Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '7.3'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7.3'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '7.0'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7.5'}]}]}], 'analyses': [{'pValue': '0.256', 'groupIds': ['OG000'], 'pValueComment': 'p value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': "The severity of Raynaud's phenomenon was assessed using the Raynaud's condition scale (ranging 0 to 10, with higher scores representing more severe Raynaud's phenomenon)", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hand Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.682', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Colchin Hand Function Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '21.8'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '23.3'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '30.3'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '27.5'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '33'}]}]}], 'analyses': [{'pValue': '0.151', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Kapandji Score (Ranging 0 to 10) - Dominant Hand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.516', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Kapandji Score (Non-dominant Hand)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '9'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.807', 'groupId': 'OG000', 'lowerLimit': '0.709', 'upperLimit': '0.880'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '0.804', 'groupId': 'OG000', 'lowerLimit': '0.723', 'upperLimit': '0.858'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '0.779', 'groupId': 'OG000', 'lowerLimit': '0.685', 'upperLimit': '0.888'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.801', 'groupId': 'OG000', 'lowerLimit': '0.715', 'upperLimit': '0.862'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '0.888', 'groupId': 'OG000', 'lowerLimit': '0.710', 'upperLimit': '0.930'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Disease-related QOL (quality of life) was measured by EuroQol-5 dimensions time trade-off (EQ-5D TTO, ranging 0 to 1, with higher values representing better QOL) values', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '81'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '80'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '75'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '88'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '83'}]}]}], 'analyses': [{'pValue': '0.656', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '0.219', 'upperLimit': '1.406'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '0.938', 'groupId': 'OG000', 'lowerLimit': '0.219', 'upperLimit': '1.375'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '1.563'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.750', 'groupId': 'OG000', 'lowerLimit': '0.063', 'upperLimit': '1.438'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '0.625', 'groupId': 'OG000', 'lowerLimit': '0.188', 'upperLimit': '1.313'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Degree of Hand Edema (Right)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '6.4'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.4'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '6.3'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '6.4'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '6.3'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema', 'unitOfMeasure': 'cm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Degree of Hand Edema (Left)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '6.2'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.3'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.3'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '6.2'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '6.3'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema', 'unitOfMeasure': 'cm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.938', 'groupId': 'OG000', 'lowerLimit': '0.594', 'upperLimit': '1.969'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '1.313', 'groupId': 'OG000', 'lowerLimit': '0.469', 'upperLimit': '1.813'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '0.5000', 'upperLimit': '1.813'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '1.250', 'groupId': 'OG000', 'lowerLimit': '0.750', 'upperLimit': '1.625'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '1.125', 'groupId': 'OG000', 'lowerLimit': '0.688', 'upperLimit': '1.563'}]}]}], 'analyses': [{'pValue': '0.372', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.125', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '1.375'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.656'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '0.063', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.688'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.625'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '0.125', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.313'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.125'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.063'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.094'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.188'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '0.125', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.313'}]}]}], 'analyses': [{'pValue': '0.188', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.188', 'groupId': 'OG000', 'lowerLimit': '1.469', 'upperLimit': '2.406'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '2.063', 'groupId': 'OG000', 'lowerLimit': '1.438', 'upperLimit': '2.500'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '2.063', 'groupId': 'OG000', 'lowerLimit': '1.625', 'upperLimit': '2.344'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '1.438', 'upperLimit': '2.563'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '2.250', 'groupId': 'OG000', 'lowerLimit': '1.313', 'upperLimit': '2.563'}]}]}], 'analyses': [{'pValue': '0.372', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.688', 'groupId': 'OG000', 'lowerLimit': '0.188', 'upperLimit': '1.625'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '0.688', 'groupId': 'OG000', 'lowerLimit': '0.563', 'upperLimit': '1.906'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '0.688', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '1.688'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.875', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '1.875'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '0.375', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '1.938'}]}]}], 'analyses': [{'pValue': '0.633', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.125', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.375'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '0.125', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.438'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '1.688'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.063', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.594'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '0.125', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.375'}]}]}], 'analyses': [{'pValue': '0.380', 'groupIds': ['OG000'], 'pValueComment': 'p-value (24 weeks-baseline)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \\< 0.05. Safety profiles were descriptively analyzed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SVF Injection Group', 'description': 'Participants received SVF treatment, and were fully followed-up for the whole scheduled period for clinical assessment. SVF extraction and injection were performed in outpatient setting within at least 1 month after baseline evaluation. All patients were regulary assessed for intervention-related adverse events and clinical efficacies at 2 weeks (2W), 6 weeks (6W), 12 weeks (12W) and 24 weeks (24W) after their procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Between July 2018 and December 2019, a total of twenty subjects were enrolled in this single center, open label, phase I trial.', 'preAssignmentDetails': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SVF Injection', 'description': 'SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles\n\nSVF injection: SVF is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with systemic sclerosis'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index (BMI) kg/m2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'BG000', 'lowerLimit': '18.2', 'upperLimit': '23.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Disease duration (years)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': "Reynaud's phenomenon duration", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Smoking history (Current or ex-)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Interstitial lung disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Types of cutaneous manisfetations (diffuse or limited)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Diffuse', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Limited', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Hand dominance (right)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Pulmonary hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'History of renal crisis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Diabetes mellitus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Osteoporosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Medication status (calcium channel blocker)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Medication status (prostacyclin)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Medication status (Aloprostadil)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Medication status (Endothelial receptor antagonist))', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Medication status (Azathioprine)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Medication status (Glucocorticoid)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Medication status (Methotrexate)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Anti-nuclear antibody', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Antinuclear autoantibodies are present in more than 90% of patients with systemic sclerosis (SSc). The presence of antinuclear antibodies is a central feature of systemic sclerosis.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Anti-centromere antibody', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Anti-centromere antibodies are autoantibodies specific to centromere function. They occur in some autoimmune diseases, freqently in limited systemic scleroderma.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Anti-Scl70 antibody', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Anti-Scl-70 autoantibodies are found in 20\\~35% of patients with systemic sclerosis, mainly in those with the diffuse form of the disease.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Anti-Ro/SSA antibody', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Anti-Ro/SSA antibodies are anti-nuclear autoantibodies that are associated with many autoimmune diseases.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}, {'title': 'Anti-U1 RNP antibody', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Anti-U1 RNP antibody is generally known to be a serological marker for mixed connective tissue disease, but can be detected also in patients with definite systemic sclerosis.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among the initially enrolled patients, one patient refused further procedures after baseline evaluation, while another patient dropped out due to complications during local anesthesia right before SVF injection (one patient dropout due to dizziness after lidocaine injection where the prepared SVF was discarded).'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-28', 'size': 382516, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-03T23:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Systemic sclerosis patients with hand disability, planning 24 weeks of follow-up period Autologous adipose tissue-derived stromal vascular fraction(SVF) injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-03', 'studyFirstSubmitDate': '2016-11-09', 'resultsFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-03', 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Raynaud's Condition Scale", 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': "The severity of Raynaud's phenomenon was assessed using the Raynaud's condition scale (ranging 0 to 10, with higher scores representing more severe Raynaud's phenomenon)"}, {'measure': 'Hand Visual Analogue Scale', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)'}, {'measure': 'Colchin Hand Function Scale', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores'}, {'measure': 'Kapandji Score (Ranging 0 to 10) - Dominant Hand', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.'}, {'measure': 'Kapandji Score (Non-dominant Hand)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.'}, {'measure': 'Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Disease-related QOL (quality of life) was measured by EuroQol-5 dimensions time trade-off (EQ-5D TTO, ranging 0 to 1, with higher values representing better QOL) values'}, {'measure': 'Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)'}, {'measure': 'Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)'}, {'measure': 'The Degree of Hand Edema (Right)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema'}, {'measure': 'The Degree of Hand Edema (Left)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema'}], 'secondaryOutcomes': [{'measure': 'Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.'}, {'measure': 'Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.'}, {'measure': 'Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.'}, {'measure': 'Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.'}, {'measure': 'Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.'}, {'measure': 'Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks', 'description': 'In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stromal vascular fraction', 'hand disability', 'mesenchymal stem cells', 'phase I trial'], 'conditions': ['Systemic Sclerosis']}, 'referencesModule': {'references': [{'pmid': '32961802', 'type': 'DERIVED', 'citation': 'Park Y, Lee YJ, Koh JH, Lee J, Min HK, Kim MY, Kim KJ, Lee SJ, Rhie JW, Kim WU, Park SH, Moon SH, Kwok SK. Clinical Efficacy and Safety of Injection of Stromal Vascular Fraction Derived from Autologous Adipose Tissues in Systemic Sclerosis Patients with Hand Disability: A Proof-Of-Concept Trial. J Clin Med. 2020 Sep 19;9(9):3023. doi: 10.3390/jcm9093023.'}]}, 'descriptionModule': {'briefSummary': 'This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months will suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population', 'detailedDescription': 'In patients with systemic sclerosis(scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relived by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognized as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. The investigators aimed to measure for the first time the safety, tolerability, and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 year old\n* Cochin Hand Function Scale (CHFS) \\> 20/90\n\nExclusion Criteria:\n\n* new vasodilators or immunosuppressive therapy for SSc in the 3 months prior to enrolment\n* new vasodilators or immunosuppressive therapy for SSc during the 6-month follow-up\n* clinical or radiological signs of digital infection\n* positive status for HIV\n* positive status for hepatitis B or C\n* positive status for human T-cell leukemia virus 1-2\n* positive status for syphilis\n* pregnancy\n* BMI less than 17kg/m2'}, 'identificationModule': {'nctId': 'NCT03060551', 'briefTitle': 'Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients', 'orgStudyIdInfo': {'id': 'SVF treatment in SSc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SVF injection', 'description': 'SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles', 'interventionNames': ['Procedure: SVF injection']}], 'interventions': [{'name': 'SVF injection', 'type': 'PROCEDURE', 'description': 'SVF is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with systemic sclerosis', 'armGroupLabels': ['SVF injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Suk-Ho Moon, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Seoul St. Mary's Hospital"}, {'name': 'Seung-Ki Kwok', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suk-Ho Moon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Suk-Ho Moon', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}