Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-05 @ 5:16 PM
Study NCT ID:
NCT00655356
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2008-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khennegan@cbrintl.com', 'phone': '720-746-1190', 'title': 'Kevin Hennegan', 'organization': 'CBR International Corp.'}, 'certainAgreement': {'otherDetails': 'Publications or presentations by the Investigator or his associates, were required to be submitted to the sponsor for review and approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous fibroblasts (azficel-T).', 'otherNumAtRisk': 98, 'otherNumAffected': 32, 'seriousNumAtRisk': 98, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.', 'otherNumAtRisk': 99, 'otherNumAffected': 33, 'seriousNumAtRisk': 99, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 20, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 30, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 45, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Spinal Column Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cervical Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Impaired Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Subarachnoid Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Wrinkle Assessment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous fibroblasts (azficel-T).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.00001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by combined treatment site.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (prior to first treatment) and 6 months post final treatment', 'description': "A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was the ITT population, defined as all randomized subjects.'}, {'type': 'PRIMARY', 'title': 'Evaluator Wrinkle Severity Assessment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous fibroblasts (azficel-T).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0075', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by combined treatment site.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (prior to first treatment) and 6 months after last treatment', 'description': "A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was the ITT population, defined as all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Subject Wrinkle Assessment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous fibroblasts (azficel-T).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.'}], 'classes': [{'title': 'Visit 3', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment', 'description': "A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was the ITT population, defined as all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Evaluator Wrinkle Severity Assessment Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous fibroblasts (azficel-T).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution.'}], 'classes': [{'title': 'Visit 3', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment', 'description': "A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was the ITT population, defined as all randomized subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous dermal fibroblasts'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Sponsor Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited between 1 November 2006 to 27 January 2007', 'preAssignmentDetails': 'Patients were enrolled and biopsied for manufacture of study product. All randomized patients were included in the Intent to Treat (ITT) population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Autologous Fibroblasts', 'description': 'Patients treated with autologous dermal fibroblasts'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients treated with placebo solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'spread': '10.38', 'groupId': 'BG000'}, {'value': '55.4', 'spread': '9.42', 'groupId': 'BG001'}, {'value': '54.6', 'spread': '9.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-09', 'studyFirstSubmitDate': '2008-03-31', 'resultsFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-09', 'studyFirstPostDateStruct': {'date': '2008-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Wrinkle Assessment Responders', 'timeFrame': 'Baseline (prior to first treatment) and 6 months post final treatment', 'description': "A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best."}, {'measure': 'Evaluator Wrinkle Severity Assessment Responders', 'timeFrame': 'Baseline (prior to first treatment) and 6 months after last treatment', 'description': "A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best."}], 'secondaryOutcomes': [{'measure': 'Subject Wrinkle Assessment Responders', 'timeFrame': 'Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment', 'description': "A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best."}, {'measure': 'Evaluator Wrinkle Severity Assessment Responders', 'timeFrame': 'Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment', 'description': "A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment of moderate to severe bilateral nasolabial fold wrinkles'], 'conditions': ['Bilateral Nasolabial Fold Wrinkles']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is at least 18 years of age\n* Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol\n* Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol\n* Ability to comply with the study requirements\n* Negative pregnancy test (Females)\n* Healthy post-auricular skin for biopsy\n\nExclusion Criteria:\n\n* Excessive dermatochalasis of the treatment area\n* Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart\n* Total area to be treated exceeds 20 cm in length\n* Physical attributes which may prevent assessment or treatment as judged by the evaluator\n* Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study\n* Previous treatment with the sponsor's product\n* History of active autoimmune disease or organ transplantation\n* Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)\n* Active or chronic skin disease\n* Known genetic disorders affecting fibroblasts or collagen\n* Active systemic infection\n* Requires chronic antibiotic or steroidal therapy\n* Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study\n* Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects\n* Known allergic reactions to agents used in preparation of treatment\n* Excessive exposure to sun without adequate sun protection"}, 'identificationModule': {'nctId': 'NCT00655356', 'briefTitle': 'Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Castle Creek Biosciences, LLC.'}, 'orgStudyIdInfo': {'id': 'IT-R-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'interventionNames': ['Biological: Autologous Human Fibroblasts (azficel-T)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Autologous Human Fibroblasts (azficel-T)', 'type': 'BIOLOGICAL', 'otherNames': ['LAVIV'], 'description': '1. Collection of 3 mm post auricular skin punch biopsies.\n2. Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '1. Collection of 3 mm post auricular skin punch biopsies.\n2. Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Brighton Medical Corporation', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Clinical Research Center', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Charlottesville Medical Research', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23454', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Institute of Anti Aging Research', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Castle Creek Biosciences, LLC.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}