Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT03506503
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2018-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D034062', 'term': 'Insomnia, Fatal Familial'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017096', 'term': 'Prion Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2018-04-14', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction assessments', 'timeFrame': '1,3,6,12 months after treatment', 'description': 'the satisfaction will be assessed after the treatment'}], 'primaryOutcomes': [{'measure': 'Dermatoscope', 'timeFrame': 'Baseline and at1,3,6,9,12 months after the treatment', 'description': 'the density of hair follicle and diameter of hair will be analized by dermatoscope before and after the treatment of Nanofat grafting.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nanofat', 'hair loss', 'prp'], 'conditions': ['Androgenic Alopecia']}, 'referencesModule': {'references': [{'pmid': '23783059', 'type': 'BACKGROUND', 'citation': 'Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.'}, {'pmid': '28875863', 'type': 'BACKGROUND', 'citation': 'Won CH, Park GH, Wu X, Tran TN, Park KY, Park BS, Kim DY, Kwon O, Kim KH. The Basic Mechanism of Hair Growth Stimulation by Adipose-derived Stem Cells and Their Secretory Factors. Curr Stem Cell Res Ther. 2017;12(7):535-543. doi: 10.2174/1574888X12666170829161058.'}, {'pmid': '28975248', 'type': 'BACKGROUND', 'citation': 'Gu Z, Li Y, Li H. Use of Condensed Nanofat Combined With Fat Grafts to Treat Atrophic Scars. JAMA Facial Plast Surg. 2018 Mar 1;20(2):128-135. doi: 10.1001/jamafacial.2017.1329.'}]}, 'descriptionModule': {'briefSummary': 'Nowadays, multiple treatment modalities have been applied clinically to treat androgenic alopecia, such as Follicular unit transplantation(FUT), finasteride, platelet-rich plasma injection(PRP), etc. In this clinical trial, the investigators aim to analyze the effect of nanofat grafting on treating androgenic alopecia in male.', 'detailedDescription': 'The investigators will treat the hair loss area of a patient by processed nanofat grafting. The participants were asked to come back 1、3、6、9、12 months after treatment for further follow-up.\n\nBefore and after the treatment, the hair and follicular will be assessed subjectively by satisfaction assessment, dermatoscope.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients with androgenic alopecia aging from 18 to 50.\n* No scars and wounds on the alopecia area.\n* No skin disease or serious cardiovascular disease.\n* Preoperative examinations remain healthy.\n\nExclusion Criteria:\n\n* Serious chronic heart, liver, kidney, blood system disease\n* Allergic diseases, skin inflammation or wounds\n* Alopecia but not androgenic alopecia\n* Acute or chronic infection\n* Take anticoagulant drugs\n* Active vitiligo, psoriasis, systemic lupus erythematosus'}, 'identificationModule': {'nctId': 'NCT03506503', 'briefTitle': 'Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia', 'organization': {'class': 'OTHER', 'fullName': 'Jinan University Guangzhou'}, 'officialTitle': 'Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia', 'orgStudyIdInfo': {'id': '2019004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'processed Nanofat grafting', 'description': 'processed autologous Nanofat will be injected into the area of the scalp with androgenic alopecia.', 'interventionNames': ['Procedure: Nanofat grafting']}], 'interventions': [{'name': 'Nanofat grafting', 'type': 'PROCEDURE', 'description': 'hair loss area will be treated by processed autologous Nanofat grafting', 'armGroupLabels': ['processed Nanofat grafting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'the first affiliated hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinan University Guangzhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Hongwei Liu', 'investigatorAffiliation': 'Jinan University Guangzhou'}}}}