STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia (NCT02503852) | Clinical Trial Compass
CompletedNot Applicable
STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia
United States71 participantsStarted 2015-11
Plain-language summary
The primary objective of this study is to evaluate the safety and feasibility of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males with a diagnosis of Alopecia Androgenetica
✓. Females with a diagnosis of Alopecia Androgenetica
✓. Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale (Figure 1)
✓. Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale (Figure 2)
✓. Provide written informed consent and comply with the study requirements
✓. For women of childbearing potential: Negative pregnancy test at screening visit plus subject agrees to maintain two forms of contraception for the duration of the study.
✓. Subject is willing to maintain a consistent hair length and natural hair color, without the use of any coloring agents, during the study period.
✓. Ability to complete study procedures, patient surveys, and pictures.
Exclusion criteria
✕. Subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening
✕. Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical study
✕. Subject who has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
✕. Subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp.
✕. Subject is currently suffering from an active autoimmune disease such as serum lupus erythematosus, or alopecia areata. Subject is currently suffering from dermatologic condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as systemic burns, etc.).
✕. History of autoimmune disease or organ transplantation or a patient on immunosuppressive medication(s).
✕. Diagnosis of cancer, receiving active treatment