Cell + Plasma Therapy for Hair Loss

(SAAA Trial)

Recruiting at 2 trial locations

Overseen By Ryan JP Welter, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Regeneris Medical

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

Disqualifiers: Autoimmune disease, Cancer, Diabetes, 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

What is the purpose of this 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 vascular fraction (AD-tSVF) and high density platelet-rich plasma concentrate (HD- PRP). Additionally, comparison with clinical outcomes of adipose-derived cellular Stromal Vascular Fraction (AD-cSVF) + AD-tSVF + HD PRP; AD-cSVF + emulsified AD-tSVF + HD- PRP; emulsified AD-tSVF + HD PRP + AD-cSVF; AD-cSVF via intravenous infusion in treatment of Scaring Alopecias and Alopecia Areata. Control will be served by use of established clinical protocol of using platelet concentrates with Matristem Matrix (Acel) injected in the same fashion as the other ARMs within this study, and comparative analyses performed at the endpoint of this study.

Will I have to stop taking my current medications?

If you are taking medications like spironolactone, finasteride, dutasteride, minoxidil, or any other oral or topical treatments for hair loss, you must stop them at least 12 months before joining the study. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the treatment Cell + Plasma Therapy for Hair Loss?

Research shows that combining stromal vascular fraction (SVF) and platelet-rich plasma (PRP) has been effective in improving joint regeneration in mice and treating conditions like osteoarthritis and degenerative disc disease in humans, suggesting potential benefits for hair loss treatment. ^{1 2 3 4 5}

Is Cell + Plasma Therapy for Hair Loss safe for humans?

Research on Cell + Plasma Therapy, which includes stromal vascular fraction (SVF) and platelet-rich plasma (PRP), has been conducted for various conditions like degenerative diseases, autoimmune diseases, and osteoarthritis. These studies generally suggest that the therapy is safe, as it has been administered to hundreds of patients without major safety concerns. ^{1 3 4 5 6}

How does the Cell + Plasma Therapy for Hair Loss treatment differ from other hair loss treatments?

This treatment is unique because it combines stromal vascular fraction (SVF) and platelet-rich plasma (PRP), both derived from the patient's own body, to potentially promote hair growth through regenerative properties. Unlike traditional hair loss treatments, which may focus on topical or oral medications, this approach uses a biocellular mixture to harness the body's natural healing processes. ^{1 3 4 5 7}

Research Team

Robert W Alexander, MD

Principal Investigator

GARM-USA

Ken Williams, DO

Principal Investigator

IIMSC

Eligibility Criteria

This trial is for adults over 18 with a biopsy-confirmed diagnosis of Scarring Alopecia or Alopecia Areata. Participants must be able to complete surveys and photo documentation, have been cancer-free for at least five years, and not use hair loss treatments within the last year. Women must test negative for pregnancy and agree to use two forms of contraception.

Inclusion Criteria

I am a male diagnosed with Scarring Alopecia or Alopecia Areata.

Being able to complete study procedures, patient surveys, and photodocumentation.

I am a male diagnosed with Scarring Alopecia or Alopecia Areata.

Exclusion Criteria

I have tried a hair loss treatment before that didn't work for me.

I haven't used any hair loss treatments, including over-the-counter or herbal, in the last 12 months.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Biocellular injections into the scalp using various combinations of AD-tSVF, HD-PRP, and AD-cSVF, with two procedures three months apart

6 months

2 procedures (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical examinations and outcome analyses

12 months

Follow-up at 6 months and 1 year

Treatment Details

Interventions

• cSVF in Normal Saline IV
• cSVF isolation and concentration
• Emulsification tSVF
• PRP Concentration
• tSVF by lipoaspiration

Trial Overview The study tests the safety and effectiveness of different combinations of adipose-derived tissue stromal vascular fraction (AD-tSVF), platelet-rich plasma concentrate (HD-PRP), and cellular Stromal Vascular Fraction (AD-cSVF) in treating scarring alopecias and alopecia areata compared to established clinical protocols.

Participant Groups

Group I: cSVF in Normal Saline IV ARM 4 Experimental Treatment 3 Interventions

cSVF + Normal Saline IV (500 cc) Infusion

Group II: Emulsification tSVF + PRP ARM 2 Experimental Treatment 3 Interventions

HD-PRP + Emulsified AD-tSVF; Intervention: Platelet Rich Plasma Concentrate

Group III: Emulsification tSVF + PRP + cSVF ARM 3 Experimental Treatment 4 Interventions

tSVF; PRP; cSVF cell enriched biocellular therapeutic mix

Group IV: Control ARM 1 Active Control 1 Intervention

Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Platelet Rich Plasma Concentrate)

cSVF in Normal Saline IV is already approved in United States for the following indications:

Approved in United States as cSVF for:

• Scarring Alopecias
• Alopecia Areata

Who Is Running the Clinical Trial?

Regeneris Medical

Lead Sponsor

Trials

4

Recruited

680+

Global Alliance for Regenerative Medicine

Collaborator

Trials

5

Recruited

760+

Findings from Research

In a study involving 10 patients with osteoarthritis, the combination of stromal vascular fraction (SVF) and platelet-rich plasma (PRP) injections led to significant improvements in pain and joint function over a 2-year period, as measured by the WOMAC score and walking distance.

The treatment demonstrated a strong safety profile, with no severe adverse events reported, indicating that SVF and PRP injections could be a safe option for managing early-stage osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis. Bansal, H., Comella, K., Leon, J., et al.[2023]

The combination of stromal vascular fraction (SVF) and platelet-rich plasma (PRP) is shown to be safe, as it did not express tumor-related genes and did not cause tumor formation in NOD/SCID mice.

This therapy demonstrated efficacy in improving joint regeneration in mice with articular cartilage injury, suggesting it could be a promising treatment option for osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transplantation of Nonexpanded Adipose Stromal Vascular Fraction and Platelet-Rich Plasma for Articular Cartilage Injury Treatment in Mice Model. Van Pham, P., Hong-Thien Bui, K., Quoc Ngo, D., et al.[2022]

In a study involving 15 patients with degenerative disc disease, the administration of stromal vascular fraction (SVF) and platelet-rich plasma (PRP) showed a strong safety profile, with no severe adverse events reported over a 12-month follow-up period.

Patients experienced significant improvements in pain ratings and mobility, as indicated by various assessments, suggesting that SVF and PRP injections may be effective treatments for degenerative disc disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the intradiscal implantation of stromal vascular fraction plus platelet rich plasma in patients with degenerative disc disease. Comella, K., Silbert, R., Parlo, M.[2022]

In a clinical case involving a patient with severe xerostomia after radiation, the combination of stromal vascular fraction (SVF) and platelet-rich plasma (PRP) followed by repeat doses of culture-expanded adipose-derived stem/stromal cells (ADSCs) showed a strong safety profile with no reported adverse events over 31 months.

The treatment led to an increase in gland size and saliva production, suggesting preliminary efficacy in improving symptoms of xerostomia, which supports the need for larger studies to explore this approach further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-man intraglandular implantation of stromal vascular fraction and adipose-derived stem cells plus platelet-rich plasma in irradiation-induced gland damage: a case study. Comella, K., Bell, W.[2023]

In a study involving 421 patients, the administration of autologous stromal vascular fraction (SVF) mixed with platelet-rich plasma (PRP) was found to be safe, with no major adverse events reported, even at doses up to 10 billion SVF cells for intravenous injections.

Adverse events were minor and primarily associated with spinal or intra-articular injections, indicating that the SVF and PRP themselves were not responsible for these issues, suggesting a favorable safety profile for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration. Karina, K., Rosliana, I., Rosadi, I., et al.[2022]

The first clinical use of stromal vascular fraction (SVF) was successfully implemented in a patient with severe psoriasis, showing significant improvement in skin quality and a reduction in psoriasis severity from a score of 50.4 to 0.3 within one month.

The treatment was safe, with no reported adverse events over a 12-month monitoring period, suggesting that SVF could be a promising and feasible option for psoriasis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-man intravenous implantation of stromal vascular fraction in psoriasis: a case study. Comella, K., Parlo, M., Daly, R., et al.[2023]

Adipose-derived stromal vascular fraction (tSVF) shows promising therapeutic efficacy, particularly in treating conditions like osteoarthritis and wound healing, based on a review of studies involving 1465 patients and 410 animals.

Mechanical fractionation methods, especially those involving centrifugation, are effective for isolating tSVF, which is crucial for maximizing its clinical benefits, although the specific preparation method does not significantly affect its therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical Fractionation of Adipose Tissue-A Scoping Review of Procedures to Obtain Stromal Vascular Fraction. Schipper, JAM., van Laarhoven, CJHCM., Schepers, RH., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis. [2023]

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

Transplantation of Nonexpanded Adipose Stromal Vascular Fraction and Platelet-Rich Plasma for Articular Cartilage Injury Treatment in Mice Model. [2022]

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

Effects of the intradiscal implantation of stromal vascular fraction plus platelet rich plasma in patients with degenerative disc disease. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

First-in-man intraglandular implantation of stromal vascular fraction and adipose-derived stem cells plus platelet-rich plasma in irradiation-induced gland damage: a case study. [2023]

5. Egypt pubmed.ncbi.nlm.nih.gov

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

First-in-man intravenous implantation of stromal vascular fraction in psoriasis: a case study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Mechanical Fractionation of Adipose Tissue-A Scoping Review of Procedures to Obtain Stromal Vascular Fraction. [2023]