Biocellular-Cellular Regenerative Treatment Scaring Alopecia and Alopecia Areata

Status unconfirmed · Not applicable

Conditions studied: Alopecia Areata, Scarring Alopecia

In brief

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.

Key facts

Study ID

NCT03078686

Run by

Regeneris Medical

People needed

60

Starts

2017-02-17

Expected to finish

2025-06-22

Last updated by the study team

2020-04-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males with a biopsy proven diagnosis of a Scaring alopecia (SA) or Alopecia Areata (AA)
• Females with a biopsy proven diagnosis of Scaring alopecia (SA) or Alopecia Areata (AA)
• Demonstrated ability to legally provide written informed consent and comply with the study requirements
• 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
• Subject is willing to maintain existing and consistent hair length and color.
• Ability to complete study procedures, patient surveys, and photodocumentation.
• Subject is ≥ 18 years of age.
• Five (5) year cancer free period without treatment and no evidence of recurrence

You may not qualify if…

• 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.
• Simultaneous treatment with an investigational product or procedure within 30 days, or planned future participation in another clinical study
• Subject has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
• Subject must have no recent PRP, biocellular treatments, micro needling, cold laser therapies, or any other scalp or hair loss treatment.
• Subject with previously diagnosed or suspected unspecified dermatologic condition, or disorders that will make hair growth difficult (such as systemic burns, etc.).
• History of or active diagnosis of systemic autoimmune disease or organ transplantation or immunosuppressive medication(s).
• Receiving active cancer treatment or have present or previous malignancies except a history of squamous or basal skin cell carcinoma with excision for cure.
• Active systemic infection at the time of enrollment. If acquired afterwards, exclusion based on clinical judgment of investigator.
• Use of chronic antibiotics and/or systemic corticosteroids.
• 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.
• Clinically significant or current medical or psychiatric illness.
• Prior surgery in the treatment area.
• 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.
• Pregnant or lactating female, or women trying to become pregnant.
• Known allergic reaction to components of study treatment and/or study injection procedure
• Subject has any disorder or any reason that may prevent compliance to study procedures and visits.
• Employees or family members of the study staff.
• Untreated or uncontrolled thyroid disorder (abnormal TSH/free T4) or diabetes mellitus (HgbA1C > 8.0).
• Subject who has a sensitive, irritated, or abraded scalp area.
• 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 it is running

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

Full record on ClinicalTrials.gov

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