Cell + Plasma Therapy for Hair Loss

(SAAA Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination treatment for certain types of hair loss, specifically scarring alopecia and alopecia areata. Researchers aim to determine if a mix of cells and plasma (a part of blood) promotes hair regrowth compared to the current standard treatment. The trial includes different groups, each trying a slightly different version of this treatment, such as cSVF in Normal Saline IV and PRP Concentration. Individuals diagnosed with these types of hair loss who haven't used hair loss medications in the past year might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in hair loss treatment.

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.

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

Research shows that the treatments in this trial have a strong safety record.

For cSVF (cellular Stromal Vascular Fraction) in Normal Saline, studies have found that injecting fewer than 10 billion SVF cells into the bloodstream is safe. A large study confirmed that SVF injections are generally safe for treating various conditions.

Emulsification tSVF, a process that breaks down cells for easier use, has also been researched. It effectively manages hair loss, and most people report satisfaction with the results without major safety issues.

Finally, PRP (Platelet-Rich Plasma) is a well-known treatment for hair loss. It is usually safe, with only minor side effects like temporary pain or mild headaches. PRP uses the patient's own blood, eliminating the risk of allergic reactions.

In summary, these treatments are well-tolerated, and existing studies suggest they are safe for humans. ^{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 use innovative approaches like cellular stromal vascular fraction (cSVF) and tissue stromal vascular fraction (tSVF) therapies. Unlike the standard of care, which typically involves platelet-rich plasma (PRP) alone, these new treatments combine PRP with concentrated stem cell-rich fractions, potentially enhancing regenerative capabilities and promoting hair growth more effectively. Additionally, the delivery methods, including IV infusion and emulsification, aim to maximize therapeutic benefits by directly targeting affected areas, possibly leading to quicker and more pronounced results.

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

Research has shown that using stromal vascular fraction (SVF) in treatments can significantly increase hair growth. One study found a 14% rise in hair count six months after using treatments enriched with SVF. Another study reported that SVF injections noticeably improved hair thickness and count. In this trial, participants may receive SVF in different forms, such as cSVF in Normal Saline IV or as part of an emulsified biocellular mixture. When combined with platelet-rich plasma (PRP), as in some trial arms, SVF also yields positive results, with increased hair density and thickness. Early findings suggest these treatments could be promising options for treating hair loss conditions like scarring alopecia and alopecia areata. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert W Alexander, MD

Principal Investigator

GARM-USA

Ken Williams, DO

Principal Investigator

IIMSC

Are You a Good Fit for This Trial?

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.

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

Pregnant or lactating female, or women trying to become pregnant

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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/PMC10205879/

Efficacy of autologous stromal vascular fraction injection in ... We concluded that SVF is an effective line of treatment for AGA with significant improvement regarding hair density, hair diameter, global photography, and ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6937163/

Stromal Vascular Fraction and its Role in the Management ... In this review, we discuss the potential influence of stromal vascular fraction from adipose tissue in the management of alopecia as well as its involvement in ...

5. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-021-02557-6

Innovative method of alopecia treatment by autologous ... This study shows that SVF is a very effective way to treat hair loss and most of subjects are satisfied with the result after treatment.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/srt.13700

Evaluation of the effects of adding an adipose tissue‐ ... examined the safety and efficacy of SVF derived from autologous adipose tissue for treating non-scarring hair loss in a systematic literature ...

7. link.springer.com link.springer.com/article/10.1007/s00403-022-02501-5

Efficacy of autologous stromal vascular fraction injection in ... We concluded that SVF is an effective line of treatment for AGA with significant improvement regarding hair density, hair diameter, global photography, and ...