Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia

Not Applicable

Not yet recruiting

• Conditions: Androgenic Alopecia
• Interventions: Procedure: autologous stromal vascular fraction

• Registration Number: NCT06326359
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

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 .

Group 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 .

Patients at both groups will receive topical and systemic antibiotics after stromal vascular fraction injection .

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03
• Study First Submitted: 2024-03-09
• Study First Submitted QC: 2024-03-16
• Last Update Submitted: 2024-03-16
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Male patients with androgenic alopecia

Exclusion Criteria

• Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.

Any other cutaneous disease as patients suffering from dermatological condition or a significant scarring in the treatment area.

Any systemic disease as autoimmune disorders , cardiac hepatic and renal patients.

patients 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
autologous stromal vascular fraction after platelet rich plasma enhanced donner site	autologous stromal vascular fraction	autologous stromal vascular fraction after platelet rich plasma enhanced donner site in male androgenic alopecia
autologous stromal vascular fraction derived from denovo	autologous stromal vascular fraction	autologous stromal vascular fraction derived from denovo in male androgenic alopecia

Primary Outcome Measures

Name	Time	Method
hair shaft thickness	at baseline and at 6 month after treatment	TrichoScan
hair density	at baseline and at 6 month after treatment	Trichoscopy