NCT02503852

STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia

Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue For Follicular Niche Stimulation in Early Stage Alopecia Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Kerastem Technologies, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Alopecia, Androgenetic

Interventions

Type	Name	Description
DEVICE	Puregraft System	The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
DEVICE	Celution System	The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
PROCEDURE	Kerastem Therapy	The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
PROCEDURE	Liposuction	Tissue collection involving the micro-harvest of subcutaneous adipose tissue.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-03-02
• Completion: 2018-03-02
• First posted: 2015-07-21
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

4 sites across 1 country: United States