Recruiting

Biocellular Treatment

Sponsor:

Regeneris Medical

Code:

NCT03078686

Conditions

Alopecia Areata

Scarring Alopecia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

tSVF by lipoaspiration

PRP Concentration

Emulsification tSVF

cSVF isolation and concentration

cSVF in Normal Saline IV

Study Details

Brief summary:

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.

Conditions

Alopecia Areata

Scarring Alopecia

Study ID

NCT03078686

Start date

Feb 17, 2017

Status verified date

Apr, 2020

Completion date

Jun 22, 2025

Anticipated

Primary completion date

Jan 22, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

-

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control ARM 1

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

experimental: Emulsification tSVF + PRP ARM 2

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

experimental: Emulsification tSVF + PRP + cSVF ARM 3

tSVF; PRP; cSVF cell enriched biocellular therapeutic mix

experimental: cSVF in Normal Saline IV ARM 4

cSVF + Normal Saline IV (500 cc) Infusion

Interventions

tSVF by lipoaspiration

Lipoaspiration Harvest tSVF closed syringe microcannula harvest, Tulip GEMS microcannula syringe system

PRP Concentration

Preparation of High Density PRP Centrifugation per manufacturer directive, Emcyte II PurePRP System

Emulsification tSVF

Preparation of emulsified tSVF harvested adipose; Use of ACM Device; Micronization of tSVF through Sterile Screen

cSVF isolation and concentration

Healeon Centrifuge (CC1000) enzymatic digestion, incubation, isolation and neutralization to prepare cSVF concentrates

cSVF in Normal Saline IV

cSVF + NS for IV Placement

Primary outcome measure

  • Safety of Intervention [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Kenneth Williams, DO

Recruiting

Irvine, California, United States, 92618

Contacts

Principal Investigator:

Ryan Welter, MD, PhD

Regeneris Medical

Recruiting

North Attleboro, Massachusetts, United States, 02760

Contacts

Principal Investigator:

Glenn C Terry, MD

Regenevita LLC

Recruiting

Stevensville, Montana, United States, 59870

Contacts

Robert W Alexander, MD

406-777-5312rwamd@garm-usa.com

Principal Investigator:

Robert W Alexander, MD

More Information

Sponsor

Regeneris Medical

Last update posted

Apr 16, 2020

Last verified

Apr, 2020

Keywords

  • Stem Cells,PRP, tSVF,cSVF,Alopecia Areata,Scarring Alopecia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Regeneris Medical on 2020-04-16.