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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
71
The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Tower Outpatient Surgery Center--Dr. Joel Aronowitz
Los Angeles, California, United States
Foundation For Hair Restoration
Miami, Florida, United States
Glasgold Surgery Group
Highland Park, New Jersey, United States
Laser & Skin Surgery Center of New York
New York, New York, United States
Safety & Tolerability Assessment of SAE/AE
Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
Time frame: Enrollment to 52 weeks
Terminal (Non-Vellus) Hair Count--Change From Baseline
Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
Time frame: Enrollment to 52 weeks
Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4
Percent of positive responses, defined by increase of 1 or more from baseline, on specific written assessment of treatment outcome by Investigators scored 1-5, value 1 is lowest, value of 5 is highest, higher values represent more positive responses
Time frame: Enrollment to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tissue collection involving the micro-harvest of subcutaneous adipose tissue.