Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02503852
Study type Interventional
Source Kerastem Technologies, LLC
Contact
Status Completed
Phase N/A
Start date November 2015
Completion date March 2, 2018

See also
  Status Clinical Trial Phase
Completed NCT01189279 - Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia Phase 1
Completed NCT05296863 - Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia Phase 3
Completed NCT05802173 - Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia Phase 2
Not yet recruiting NCT03154528 - Role of Vitamin D in Androgenetic Alopecia
Terminated NCT02676310 - Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA) Phase 1
Recruiting NCT05910450 - A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss Phase 3
Completed NCT01325337 - Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia Phase 2
Not yet recruiting NCT02316418 - Hairstetics™ Anchoring System in Female Pattern Hair Loss (HAS-FPHL) N/A
Recruiting NCT06263413 - Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions
Recruiting NCT05681897 - Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia N/A
Completed NCT05244980 - A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA) Phase 1
Completed NCT01904721 - A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA) Phase 2
Completed NCT03004469 - Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia Phase 3
Recruiting NCT05914805 - A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) Phase 3
Completed NCT04913519 - A Phase 1 Study of TDM-105795 Topical Solution in Male Subjects With Androgenetic Alopecia (AGA) Phase 1