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NCT06326359 Clinical Trial

Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia

Androgenic Alopecia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06326359
Other study ID # Soh-Med-24-02-03MD
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date October 2026

Study information
Verified date March 2024
Source Sohag University
Contact dina A mahmoud, assistant lecturer
Phone 01097185631
Email dr.dondon123@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date October 2026
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• autologous stromal vascular fraction
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Outcome
Type Measure Description Time frame Safety issue
Primary hair density Trichoscopy at baseline and at 6 month after treatment
Primary hair shaft thickness TrichoScan at baseline and at 6 month after treatment
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