Biocellular Stem/Stromal Therapy for Hair Loss

(STRAAND Trial)

Overseen By Robert W. Alexander, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Healeon Medical Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

Purpose The primary objective of this study is to evaluate the safety and efficacy of the use of a biocellular mixture of emulsified adipose-derived tissue stromal vascular fraction (AD-tSVF) and high density platelet-rich plasma concentrate (HD- PRP) as compared with adipose-derived cell-enriched SVF (AD-cSVF) + AD-tSVF and HD- PRP concentrates in treatment of androgenetic alopecia (AGA) and Female Pattern Hair Loss (FPHL). Assigned Interventions 1. HD-PRP + Matristem Matrix (ACell) 2. Experimental: HD-PRP + Emulsified AD-tSVF 3. Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF Device: Tulip Microcannula Closed Syringe For All Lipoaspiration (2.11 mm Diameter, offset Carraway) Centrifugation technique to acquire concentrated platelets (per manufacturer's approved protocol) Healeon ACM Emulsification System that prepares microcannula harvested AD-tSVF for small needle (25g) retrograde threaded intradermal scalp injection. Healeon Centricyte 1000 system for cellular isolation of AD-cSVF from AD-tSVF and testing by Flow Cytometry (ORFLO MoxiFlow) Procedure: Closed syringe microcannula lipoaspiration (AD-tSVF) Procedure: Emulsification of AD-tSVF via Healeon ACM Protocol (Newbury Park, CA, USA) Procedure: Biocellular mix of emulsified AD-tSVF and HD-PRP for intradermal injection in scalp; (Arm 2) Procedure: Cellular isolation (AD-cSVF) Centricyte 1000 incubation/shaker system using GMP certified, sterile Liberase MNP-S (Roche #06297790001) for enzymatic digestion manufacturer standard protocol. Creation of emulsified AD-tSVF + PRP + cell-enriched AD-cSVF for intradermal injection in scalp (Arm 3) Sham Comparator: No Fat Control using Emcyte II PRP Concentrate + Matristem (Acell) for subcutaneous scalp injection patterned per square centimeter of scalp. Procedure: Emcyte Pure PRP® II system to concentrate Platelets via using manufacturer standard protocol

Research Team

Kenneth Williams, DO

Principal Investigator

Irvine Institute Medicine & Cosmetic Surgery

Ryan Welter, MD, PhD, MD,PhD

Principal Investigator

Regeneris

Marco Barusco, MD

Principal Investigator

Brusco Clinic

Eligibility Criteria

This trial is for adults with hair loss due to Androgenetic Alopecia or Female Pattern Hair Loss, who haven't responded to previous treatments. Participants must be willing to maintain their hair and avoid pregnancy. Exclusions include those on certain medications, with scalp conditions, autoimmune diseases, recent cancer treatment, or significant health issues.

Inclusion Criteria

I am a male diagnosed with male pattern baldness.

I am a woman experiencing hair loss.

Ability to complete study procedures, patient surveys, and photodocumentation

Exclusion Criteria

Pregnant or lactating female, or women trying to become pregnant

Simultaneous treatment with an investigational product or procedure within 30 days, or planned future participation in another clinical study

I have an autoimmune disease, have had an organ transplant, or am on immunosuppressive drugs.

Treatment Details

Interventions

• AGA Biocellular Stem/Stromal Hair Regenerative Study (Stem Cell Therapy)

Trial Overview The study tests the safety and effectiveness of injecting a biocellular mix into the scalp. It compares different combinations of high-density platelet-rich plasma (HD-PRP), adipose-derived stem/stromal cells (AD-tSVF and AD-cSVF), and MatriStem Matrix against a control group receiving standard care.

Participant Groups

Group I: ARM 3 Experimental Treatment 7 Interventions

Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF; Intervention: Intradermal injections of hair loss 1. Platelet Rich Plasma 2. Adipose Derived Stem/Stromal Cells 3. Stem/Stromal Cell Isolation 4. Intradermal injections of hair loss

Group II: ARM 2 Active Control 5 Interventions

1. Experimental: HD-PRP + Emulsified AD-tSVF; Intervention: 2. Platelet Rich Plasma 3. Adipose Derived Stem/Stromal Cells 4. Intradermal injections of hair loss

Group III: ARM 1 Active Control 4 Interventions

Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Intradermal injections of hair loss 3) Platelet Rich Plasma 4) Matristem Matrix (ACell)

Who Is Running the Clinical Trial?

Healeon Medical Inc

Lead Sponsor

Trials

9

Recruited

710+

Terry, Glenn C., M.D.

Collaborator

Trials

5

Recruited

460+

Ministry of Health, Honduras

Collaborator

Trials

4

Recruited

2,400+

Robert W. Alexander, MD

Collaborator

Trials

4

Recruited

220+