Treatment for Scarring Alopecia and Alopecia Areata using Stem Cells and Platelet Concentrates

Biocellular Regenerative Therapy in Treating Scaring Alopecias and Alopecia Areata: Use of High Density Platelet-Rich Plasma Concentrates and Cell-Enriched Emulsified Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF)

This study is testing a new treatment using a mix of stem cells and platelet-rich plasma to see if it can help people with scarring alopecia and alopecia areata.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Regeneris Medical (Academic / other)
• Locations: 3 sites (Irvine, California and 2 other locations)
• Trial ID: NCT03078686 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of a biocellular mixture combining emulsified adipose-derived tissue stromal vascular fraction (AD-tSVF) and high-density platelet-rich plasma (HD-PRP) for treating scarring alopecia and alopecia areata. It involves a randomized, multi-center design with blinding for independent observers and patient satisfaction assessments. Participants will receive various combinations of AD-tSVF and HD-PRP, compared against a control group using established treatment protocols. The aim is to determine the optimal therapeutic profile for these conditions through advanced regenerative medicine techniques.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 18 and older with a biopsy-proven diagnosis of scarring alopecia or alopecia areata.

Not a fit: Patients who have recently used medications for hair loss treatment or have a history of cancer within the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve hair regrowth and scalp health for patients suffering from scarring alopecia and alopecia areata.

How similar studies have performed: Other studies have shown promising results using similar regenerative approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Males with a biopsy proven diagnosis of a Scaring alopecia (SA) or Alopecia Areata (AA)
2. Females with a biopsy proven diagnosis of Scaring alopecia (SA) or Alopecia Areata (AA)
3. Demonstrated ability to legally provide written informed consent and comply with the study requirements
4. For women of childbearing potential with screening negative pregnancy test and subject agrees to avoid pregnancy with two forms of contraception for the duration of study
5. Subject is willing to maintain existing and consistent hair length and color.
6. Ability to complete study procedures, patient surveys, and photodocumentation.
7. Subject is ≥ 18 years of age.
8. Five (5) year cancer free period without treatment and no evidence of recurrence

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Exclusion Criteria:

1. Subjects who have used oral spironolactone, finasteride, dutasteride, minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 12 months of study screening.
2. Simultaneous treatment with an investigational product or procedure within 30 days, or planned future participation in another clinical study
3. Subject has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
4. Subject must have no recent PRP, biocellular treatments, micro needling, cold laser therapies, or any other scalp or hair loss treatment.
5. Subject with previously diagnosed or suspected unspecified dermatologic condition, or disorders that will make hair growth difficult (such as systemic burns, etc.).
6. History of or active diagnosis of systemic autoimmune disease or organ transplantation or immunosuppressive medication(s).
7. Receiving active cancer treatment or have present or previous malignancies except a history of squamous or basal skin cell carcinoma with excision for cure.
8. Active systemic infection at the time of enrollment. If acquired afterwards, exclusion based on clinical judgment of investigator.
9. Use of chronic antibiotics and/or systemic corticosteroids.
10. Use of systemic agents that increase bleeding or clotting, or disorders associated with these effects, including patients receiving GIIB/IIIa inhibitors in the 2 weeks prior to the study procedure through to 1 week after the study procedure.
11. Clinically significant or current medical or psychiatric illness.
12. Prior surgery in the treatment area.
13. Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise dermatologic, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk of increased morbidity or mortality.
14. Pregnant or lactating female, or women trying to become pregnant.
15. Known allergic reaction to components of study treatment and/or study injection procedure
16. Subject has any disorder or any reason that may prevent compliance to study procedures and visits.
17. Employees or family members of the study staff.
18. Untreated or uncontrolled thyroid disorder (abnormal TSH/free T4) or diabetes mellitus (HgbA1C \> 8.0).
19. Subject who has a sensitive, irritated, or abraded scalp area.
20. Clinically significant abnormal findings on laboratory screening panels:

    * Hemoglobin \> or = 10 g/dL
    * Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin levels \> 1.5 times the upper limit of normal range prior to randomization.
    * Chronic renal insufficiency as defined as a serum creatinine \> 1.2 mg/dL for women and \> 1.5 mg/dL for men.
    * Elevated PT/PTT, INR,
    * Platelet count \< 100 x 109/L

Where this trial is running

Irvine, California and 2 other locations

• Kenneth Williams, DO — Irvine, California, United States (Recruiting)
• Regeneris Medical — North Attleboro, Massachusetts, United States (Recruiting)
• Regenevita LLC — Stevensville, Montana, United States (Recruiting)

Study contacts

• Principal investigator: Ken Williams, DO — Iimsc
• Study coordinator: Ryan Welter, MD, PhD

Conditions Alopecia Areata; Scarring Alopecia; Stem Cells,PRP, tSVF,cSVF,Alopecia Areata,Scarring Alopecia