Biocellular Stem/Stromal Therapy for Hair Loss

(STRAAND Trial)

Overseen By Robert W. Alexander, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Healeon Medical Inc

Must not be taking: Spironolactone, Finasteride, Dutasteride, Minoxidil

Disqualifiers: Autoimmune diseases, Active infection, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 months

60 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

Yes, you must stop taking certain medications for hair loss, like spironolactone, finasteride, dutasteride, and minoxidil, at least 12 months before joining the study.

What data supports the effectiveness of the treatment for hair loss in the Biocellular Stem/Stromal Therapy for Hair Loss trial?

Research shows that regenerative therapies, including stem cell treatments, have been effective in improving hair growth and density in androgenetic alopecia (AGA). Studies using micrografts and mesenchymal stem cells have demonstrated increased hair count and density, suggesting potential benefits for hair restoration. ^{1 2 3 4 5}

Is Biocellular Stem/Stromal Therapy for Hair Loss safe for humans?

Stem cell therapies, including those derived from hair follicles and adipose tissue, have shown promising safety profiles in early studies for hair loss, with minimal adverse effects reported. However, more research is needed to confirm long-term safety. ^{1 6 7 8 9}

How does the Biocellular Stem/Stromal Therapy for Hair Loss differ from other treatments for androgenetic alopecia?

This treatment is unique because it uses regenerative medicine techniques, specifically autologous micrografts, to enhance the body's natural ability to regenerate hair, unlike traditional treatments like minoxidil and finasteride which have moderate results and potential side effects. The use of stem/stromal cells in this therapy aims to improve hair growth and density by altering the scalp environment and promoting the development of hair follicles. ^{2 4 5 6 10}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive biocellular injections of HD-PRP and AD-tSVF, with or without AD-cSVF, for hair regeneration

6 months

2 procedures, 3 months apart

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up examinations at 6 months and 1 year

Treatment Details

Interventions

• AGA Biocellular Stem/Stromal Hair Regenerative Study

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+

Findings from Research

The RAMACAP helmet-type low-level laser therapy (LLLT) device significantly improved hair density and diameter in patients with androgenetic alopecia after 24 weeks of treatment, outperforming a sham device in a study of 40 participants.

The treatment was generally safe, with only minor side effects like temporary hair shedding and scalp itching reported, indicating that it could be a viable option for both men and women suffering from hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy for the treatment of androgenetic alopecia in Thai men and women: a 24-week, randomized, double-blind, sham device-controlled trial. Suchonwanit, P., Chalermroj, N., Khunkhet, S.[2020]

Cetosomal minoxidil 5% was found to be effective in treating androgenetic alopecia (AGA), with 52% of patients showing significant to excellent improvement after 16 weeks, compared to 68% in the combination group with finasteride.

The cetosomal formulation demonstrated good tolerability, with 64% of patients rating it as excellent, suggesting it may be a safer alternative to traditional alcoholic minoxidil solutions, which are often associated with adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness, Safety, and Tolerability of Cetosomal Minoxidil 5% Alone and a Fixed Drug Combination of Cetosomal Minoxidil 5% With Finasteride 0.1% in the Management of Androgenetic Alopecia (Inbilt Study). Kerure, A., Ghalla, M., Mahajan, S., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A clinical trial of treating androgenic alopecia with mesenchymal stem cell suspension derived from autologous hair follicle. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Progenitor-cell-enriched micrografts as a novel option for the management of androgenetic alopecia. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Stem cell therapy as a novel therapeutic intervention for resistant cases of alopecia areata and androgenetic alopecia. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Advancing Regenerative Cellular Therapies in Non-Scarring Alopecia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Hair morphogenesis in vitro: formation of hair structures suitable for implantation. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Combination of adipose-derived stem cell conditioned media and minoxidil for hair regrowth in male androgenetic alopecia: a randomized, double-blind clinical trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Low-level laser therapy for the treatment of androgenetic alopecia in Thai men and women: a 24-week, randomized, double-blind, sham device-controlled trial. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma and Stem Cells for Hair Growth: A Review of the Literature. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness, Safety, and Tolerability of Cetosomal Minoxidil 5% Alone and a Fixed Drug Combination of Cetosomal Minoxidil 5% With Finasteride 0.1% in the Management of Androgenetic Alopecia (Inbilt Study). [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Cellular Senescence: Ageing and Androgenetic Alopecia. [2023]