Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia

NCT ID: NCT06326359

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2026-10-31

Brief Summary

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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

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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 .

Conditions

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Androgenic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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autologous stromal vascular fraction derived from denovo

autologous stromal vascular fraction derived from denovo in male androgenic alopecia

Group Type ACTIVE_COMPARATOR

autologous stromal vascular fraction

Intervention Type PROCEDURE

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

autologous stromal vascular fraction after platelet rich plasma enhanced donner site

autologous stromal vascular fraction after platelet rich plasma enhanced donner site in male androgenic alopecia

Group Type ACTIVE_COMPARATOR

autologous stromal vascular fraction

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Dina Ahmed Mahmoud

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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dina A mahmoud, assistant lecturer

Role: CONTACT

01097185631

reham E Elsharkawy, Professor

Role: CONTACT

01006809003

Other Identifiers

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Soh-Med-24-02-03MD

Identifier Type: -

Identifier Source: org_study_id

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