Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-28 @ 1:51 AM
Study NCT ID:
NCT06326359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-16', 'studyFirstSubmitDate': '2024-03-09', 'studyFirstSubmitQcDate': '2024-03-16', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hair density', 'timeFrame': 'at baseline and at 6 month after treatment', 'description': 'Trichoscopy'}, {'measure': 'hair shaft thickness', 'timeFrame': 'at baseline and at 6 month after treatment', 'description': 'TrichoScan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autologous stromal vascular fraction', 'platelet rich plasma', 'male androgenic alopecia'], 'conditions': ['Androgenic Alopecia']}, 'descriptionModule': {'briefSummary': 'Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia', 'detailedDescription': '40 Patients with androgenic alopecia will be randomly divided into 2 groups Group A (20): will receive 2 session of stromal vascular fraction directly after fat harvesting and processing and stromal vascular fraction extraction with 1 month interval .\n\nGroup B(20): will be injected with 2 session of Platelet rich plasma 3weeks interval at site of fat harvesting and will be followed 1 month later with fat aspiration from site where Platelet rich plasma was previously injected and this fat will undergo fat processing and stromal vascular fraction extraction followed by 2 session of stromal vascular fraction injection at scalp 1month interval .\n\nPatients at both groups will receive topical and systemic antibiotics after stromal vascular fraction injection .'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients with androgenic alopecia\n\nExclusion Criteria:\n\n* Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.\n\nAny other cutaneous disease as patients suffering from dermatological condition or a significant scarring in the treatment area.\n\nAny systemic disease as autoimmune disorders , cardiac hepatic and renal patients.\n\npatients who received minoxidil or any other oral, topical medications (including herbal medications) or injection procedures for the treatment of hair loss within 6 months prior to the study, or finasteride or dutasteride within 12 months of the study'}, 'identificationModule': {'nctId': 'NCT06326359', 'briefTitle': 'Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Evaluation of Safety and Efficacy of Autologous Stromal Vascular Fraction Derived From Denovo Versus Platelet Rich Plasma Enhanced Donner Site in Treatment of Male Androgenic Alopecia', 'orgStudyIdInfo': {'id': 'Soh-Med-24-02-03MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'autologous stromal vascular fraction derived from denovo', 'description': 'autologous stromal vascular fraction derived from denovo in male androgenic alopecia', 'interventionNames': ['Procedure: autologous stromal vascular fraction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'autologous stromal vascular fraction after platelet rich plasma enhanced donner site', 'description': 'autologous stromal vascular fraction after platelet rich plasma enhanced donner site in male androgenic alopecia', 'interventionNames': ['Procedure: autologous stromal vascular fraction']}], 'interventions': [{'name': 'autologous stromal vascular fraction', 'type': 'PROCEDURE', 'description': 'autologous stromal vascular fraction injection as 2 sessions with 1 month interval at arm 1 arm 2: will receive 2 sessions of PRP with 3 weeks interval followed by stromal vascular fraction injection as 2 sessions with 1 month interval', 'armGroupLabels': ['autologous stromal vascular fraction after platelet rich plasma enhanced donner site', 'autologous stromal vascular fraction derived from denovo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'dina A mahmoud, assistant lecturer', 'role': 'CONTACT', 'email': 'dr.dondon123@gmail.com', 'phone': '01097185631'}, {'name': 'reham E Elsharkawy, Professor', 'role': 'CONTACT', 'phone': '01006809003'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Dina Ahmed Mahmoud', 'investigatorAffiliation': 'Sohag University'}}}}