Alopecia, Androgenetic Clinical Trial
Official title:
Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue For Follicular Niche Stimulation in Early Stage Alopecia Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial
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.
The STYLE Trial is a prospective, randomized, multi-center device trial intended to evaluate
the safety and efficacy 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. Patients may be included if they
are undergoing an elective cosmetic liposuction. Following informed consent and screening
evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo
a fat harvest using local anesthesia with or without conscious sedating. Subjects will be
randomly assigned to receive a fat graft cell enriched with ADRCs (available in two different
doses),a fat graft without cell enrichment using a visually-matched blood saline solution
(fat alone control), or a saline injection (no-fat control) in a 2:2:2:1 ratio.
While undergoing liposuction, lipoaspirate will be processed in the Puregraft System to
remove the lipoaspirate of impurities and in the Celution System to isolate and concentrate
ADRCs. After the liposuction is completed), patients will have, under a ring block local
anesthesia (see further description below), a subcutaneous scalp injection of either
Puregraft purified autologous fat or saline (no-fat control) followed by a separate second
injection, of either ADRCs (available in two different doses),a visually-matched blood saline
solution (fat alone control), or saline (no-fat control) in a 2:2:2:1 ratio.
The STYLE Clinical Trial will have a sample size of 70 patients at up to eight (8) centers.
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