Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 10:48 PM
Study NCT ID:
NCT01309061
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2011-03-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005150', 'term': 'Facial Hemiatrophy'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2011-03-02', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The volume change of fatty layer', 'timeFrame': '24 weeks', 'description': 'To evaluate the volume change of fatty layer using 3D camera.'}], 'secondaryOutcomes': [{'measure': 'Clinical lab tests', 'timeFrame': '24 weeks', 'description': 'To assess the expression change of growth factors after tissue biopsy.'}, {'measure': 'Fat absorption rate', 'timeFrame': '24 weeks', 'description': 'To estimate the fat absorption rate using 3D computerized tomography and 3D camera.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Progressive Hemifacial Atrophy', "Romberg's Disease"]}, 'referencesModule': {'references': [{'pmid': '22907186', 'type': 'RESULT', 'citation': 'Koh KS, Oh TS, Kim H, Chung IW, Lee KW, Lee HB, Park EJ, Jung JS, Shin IS, Ra JC, Choi JW. Clinical application of human adipose tissue-derived mesenchymal stem cells in progressive hemifacial atrophy (Parry-Romberg disease) with microfat grafting techniques using 3-dimensional computed tomography and 3-dimensional camera. Ann Plast Surg. 2012 Sep;69(3):331-7. doi: 10.1097/SAP.0b013e31826239f0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (MSCs) in patient with progressive hemifacial atrophy.', 'detailedDescription': "Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.\n\nWith the recent demonstration of MSC homing properties, intramuscular aplications of MSCs to cell-damaged diseases have increased.\n\nIn a human clinical trial, five patients who had suffered a progressive hemifacial atrophy( Romberg's disease) were intramuscular administered autologous hAdMSCs (1×10e7 cells/500ul) with autologous microlipoinjection one time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who understand and sign the consent form for this study.\n* Age :18-75, males and females.\n* Patients with symptom of hemifacial atrophy but not progress disease.\n\nExclusion Criteria:\n\n* Patients with currently progressive hemifacial atrophy.\n* Women who are pregnant or breast feeding or planning to become pregnant during the study.\n* Subjects who don't understand purpose and method for this study.\n* Patients with psychical disorder or drug and alcohol addiction.\n* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.\n* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.\n* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria"}, 'identificationModule': {'nctId': 'NCT01309061', 'briefTitle': "The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'R-Bio'}, 'officialTitle': "Preliminary Investigation of the Effect of Human Adipose Tissue-derived Mesenchymal Stem Cell in Progressive Hemifacial Atrophy(Romberg's Disease)", 'orgStudyIdInfo': {'id': 'KSC-Facial-Stem'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Autologous Adipose Tissue derived MSCs Transplantation', 'type': 'PROCEDURE', 'description': 'Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'ASAN Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jong-Woo Choi, M.D.Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R-Bio', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}