Biocellular-Cellular Regenerative Treatment Scaring Alopecia and Alopecia Areata
United States60 participantsStarted 2017-02-17
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.