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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for hair loss conditions known as androgenetic alopecia (AGA) and female pattern hair loss (FPHL). Researchers are testing various combinations of platelet-rich plasma (a blood component believed to aid healing) and stem cells to determine if they promote hair growth. The goal is to identify the safest and most effective combination. Individuals with hair loss without scarring or autoimmune disorders, who have not used hair loss treatments in the past year, might be suitable for this trial. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking hair loss solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both treatments being tested—HD-PRP with emulsified AD-tSVF and HD-PRP with emulsified AD-tSVF plus AD-cSVF—have been studied for their safety in treating hair loss.

For the combination of HD-PRP and emulsified AD-tSVF, studies have not identified any major side effects. This treatment has been used in other hair loss studies and is generally well-tolerated by participants. It aims to encourage hair regrowth using concentrated platelet-rich plasma (a part of the blood that aids healing) mixed with processed fat tissue cells.

Regarding the combination of HD-PRP, emulsified AD-tSVF, and AD-cSVF, research also indicates safety. This mix is intended to enhance the treatment's regenerative effects by adding more stem cells. Studies suggest it is well-tolerated, with no major safety concerns reported.

These treatments are being tested in early-phase trials, which means they have demonstrated enough safety in initial studies to warrant further testing. This phase focuses heavily on safety, so any significant issues would likely have been identified. Participants in these trials are usually monitored closely for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for hair loss because they combine cutting-edge biocellular approaches with traditional methods. Unlike standard treatments like topical minoxidil or oral finasteride, these investigational therapies use a mix of Platelet Rich Plasma (PRP) and Adipose Derived Stem/Stromal Cells. One arm of the study even includes an emulsified version of two types of stromal vascular fractions, which could potentially enhance the treatment's effectiveness by harnessing the body's regenerative capabilities. This innovative approach aims to not only stop hair loss but also stimulate new hair growth more effectively than current options.

What evidence suggests that this trial's treatments could be effective for hair loss?

This trial will compare different biocellular stem/stromal therapies for hair loss. Research has shown that platelet-rich plasma (PRP) combined with processed fat tissue can aid in hair regrowth. In this trial, one group will receive PRP with emulsified adipose-derived stem/stromal cells (AD-tSVF), while another group will receive PRP with Matristem Matrix (ACell), the current standard of care. A third group will receive PRP with both emulsified AD-tSVF and emulsified AD-cSVF. Studies have found that PRP can enhance the growth potential of stem cells from fat, potentially leading to improved hair growth.

When PRP is used with two types of processed fat tissue, initial findings suggest this combination can further enhance hair regrowth by increasing cell activity and supporting hair follicles. Evidence shows these treatments have promising effects on hair loss conditions like male and female pattern baldness, with some studies indicating increased hair density and thickness.

Overall, these treatments are under study for their potential to effectively treat hair loss by harnessing the natural healing properties of stem cells and platelets. ^{1 5 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03078686

Study Details | NCT03078686 | Biocellular-Cellular ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4622412/

The Effect of Platelet-Rich Plasma in Hair Regrowth Platelet-rich plasma greatly potentiates insulin-induced adipogenic differentiation of human adipose-derived stem cells through a serine/threonine kinase ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02849470

AGA Biocellular Stem/Stromal Hair Regenerative Study 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 ...

4. belgraviacentre.com belgraviacentre.com/blog/adipose-and-prp-regenerative-therapy-for-hair-loss-trial-announced

Adipose and PRP Regenerative Therapy for Hair Loss Trial ... This new trial aims to compare the results of three different types of treatment courses each featuring adipose-based treatments combined with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8588812/

Effects of Adipose-Derived Stem Cells and Platelet-Rich ... The present study was conducted to compare the effects of different concentrations of exosomes derived from human adipose stem cells (hASCs) and platelet-rich ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6098866/

Therapeutic Potential of Stem Cells in Follicle Regeneration We know that stem cells can be used to regenerate hair in several therapeutic strategies: reversing the pathological mechanisms which contribute to hair loss.

7. withpower.com withpower.com/trial/phase-cicatrix-1-2017-03124

Cell + Plasma Therapy for Hair Loss (SAAA Trial) 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 ...

8. belgraviacentre.com belgraviacentre.com/blog/prp-treatment-trialled-for-scarring-alopecia-and-alopecia-areata

PRP Treatment Trialled for Scarring Alopecia and ... Researchers' aims are to discover the safety and efficacy of using a 'biocellular mixture of emulsified adipose-derived tissue stromal vasular fraction (AD-tSVF) ...