Efficacy of Stromal Vascular Fraction Versus Platelet Rich Plasma in Treatment of Androgenitic Alopecia

Efficacy of Stromal Vascular Fraction Versus Platelet Rich Plasma in Treatment of Androgenitic Alopecia:Randomized Clinical Trial

The goal of this randomized controlled clinical trial is to test the efficacy & safety of stromal vascular fraction in treatment of AGA & compare it to PRP The main questions it aims to answer are:

• efficacy & safety of SVF for treatment of AGA patients
• comparing it to PRP in treatment of AGA Participants will receive a single session of SVF in one half of the scalp & a single session of PRP in the other half.

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Procedure: stromal vascular fraction or platelet rich plasma

Detailed Description

• History taking from the patients is done about age, duration of the disease previous treatment, medical, surgical history & family history.
• Patients are subjected to clinical evaluation of severity using Hamilton classification & photographing of the patients. In addition, tricoscopic evaluation of hair density & thickness.
• Randomization of patients: The side assigned to SVF treatment is randomized by closed envelop technique.
• Isolation of SVF:

After choosing the site of aspiration (either the hip or the abdomen), sterilization of the site is done.Then, local anesthesia (1 ml of lidocaine 2%) is injected intradermally, small incision (3 ml) is made using sterile blade for insertion of the canula. After that, the tumescence is created with a multiperforated blunt cannula injecting the tumescent solution (0.05% lidocaine in saline solution &1: 200000 epinephrine) then we wait for 20 minutes, followed by harvesting of 50 ml of fat using 2.4 mm microport harvester cannulas with barbed & beveled 1 mm ports. Processing of fat is started by washing of obtained fat using ringer lactate which is left for 10 minutes to decant & elements in the lowest layer is discarded. After that, fat is passed 30 times between two Luer lock 20-ml syringes connected to each other by connectors 2.4mm, 1.4mm, and 1.2mm arranged from higher diameter to lower diameter with minimal pressure force in order to achieve successful mechanical micronization of fat. Then, centrifugation of the micronized fat is done (2000 g for 15 minutes). As a result of this process, 3 layers (oil, fat & SVF) are obtained depending on the density with the SVF pellet suspended in the bottom. After isolation of SVF in one -ml syringes (4-5ml), the scalp is injected with 0.1 ml/cm2 of SVF intra-dermally with small 30 G needle.

- Isolation of platelet-rich plasma: Under sterilized conditions, 8 cc of whole blood are withdrawn from the antecubital vein of each patient. Blood is taken in commercially available PRP kit (Tray Life Tube Gel) containing preformed gel comprising a mixture of polymers that separated plasma, and sodium citrate solution which acts as an anticoagulant. And then is centrifuged at 650 g for 10 minutes. After centrifugation, red blood cells are trapped under the gel, and the upper 1 mL of platelet-poor plasma is removed, and 5 mL PRP obtained.

• Injection of stromal vascular fraction and platelet-rich plasma: Scalp of every patient is divided into two equal halves by the median plane (split scalp), leaving 1.5 cm on both sides of the median plane to minimize diffusion of the injected material to the other side, Lignocaine gel is applied on scalp of patients half an hour before injection followed by sterilization of the site of injection. Then, SVF is injected in one half of scalp & PRP is injected in the other half of scalp, Intra-dermal injections are given by using insulin syringes at 0.1 ml/cm2 interval. Each patient undergoes one session of injection and is followed up for 6 months after the last session.
• Assessment Three & six months After PRP and SVF therapy, the improvement is assessed using pre- and post-treatment photographs according to Hamilton Norwood scale, patient global assessment (PaGAS) scores, physician global assessment (PhGAS) scores, patient satisfaction score, pull test & tricoscopic assessment of:The trichoscopic features of the four areas (bilateral frontal & occipital areas) which are received and analyzed using the trichoscale analysis system of the fotofinder in an area of approximately 1cm2 (0.903 cm2) e.g.hair density & thickness.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa S Aamer, resident; Phone Number: 01116783121 01017762819; Email: asmaaaamer0@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr El Ainy hospital
    • Contact: Asmaa S Aamer, resident; Phone Number: 01116783121 01017762819; Email: asmaaaamer0@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older.
• Hamilton score I to VI in male patients.

Exclusion Criteria:

• Patients with active infection, malignancy, autoimmune disease, and on current anticoagulant therapy.
• Patient on chemotherapy during the last 5 years.
• patients on topical or systemic treatment of AGA

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: stromal vascular fraction side; stromal vascular fraction will be injected in one half of the frontal scalp	Procedure: stromal vascular fraction or platelet rich plasma; stromal vascular fraction will be injected in one half of the scalp & PRP will be injected in the other half
Active Comparator: PRP side; PRP will be injected in the other half of frontal scalp	Procedure: stromal vascular fraction or platelet rich plasma; stromal vascular fraction will be injected in one half of the scalp & PRP will be injected in the other half

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of SVF versus PRP	to compare the mean difference in hair density,thickness, Norwood Hamilton scale, patient global assessment, patient satisfaction & physician global assessment scores between SVF & PRP.	at 3 & 6 months after the sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detecting efficacy of SVF in treatment of AGA	To detect provment in hair thickness & diameter	at 3 & 6 months

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: stromal vascular fraction - PRP- androgenetic alopecia
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: MS-260-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No