Pipeline

Kerastem has an active phase II clinical study in the United States.

KERASTEM HAIR THERAPY

PRE
CLINICAL
PHASE I-II
PHASE III
PIVOTAL
COMMERCIALLY
AVAILABLE

UNITED STATES

CE MARK COUNTRIES (i.e. Europe)

JAPAN

CLINICAL TRIAL WEBSITE

IDE 16488

STYLE – US Phase II Clinical Study

Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue for Follicular Niche Stimulation in EarlY ALopEcia Androgenetica (STYLE) : A randomized, blinded, placebo controlled trial.

70 patients
Up to 8 sites
4 arms

Arm 1 (20 Patients)

Low dose of adipose derived regenerative cells with purified adipose tissue

Arm 2 (20 Patients)

High dose of adipose derived regenerative cells with purified adipose tissue

Arm 3 (20 patients)

Fat-alone (adipose) control

Arm 4 (10 patients)

Saline control

Primary Endpoint – safety & tolerability
Secondary Endpoints – change in hair growth & density

 

STYLE Trial

Kerastem’s STYLE trial is a prospective, randomized, placebo-controlled, multi-center study aimed at investigating the safety and efficacy (e.g., hair growth) of Kerastem Hair Therapy in females and males with pattern hair loss (alopecia). This form of hair loss, known as Androgenic Alopecia (AGA), is the most common form of alopecia in the United States.

CLINICAL TRIALS

Kerastem’s clinical development program consists of rigorous, well-designed, controlled studies targeting hair indications that are inadequately addressed by currently available therapeutic options. Adipose (fat)-based therapeutic formulations are derived from Adipose Derived Regenerative Cells.

Alopecia ANDROGENETICA

Kerastem has received approval from the US FDA to enroll the STYLE Trial, a randomized, double blind, placebo-controlled, Phase II clinical trial of 70 patients suffering with AGA. This trial is based on previous clinical work conducted in Japan with one of the world’s leading centers for regenerative aesthetics as well as in the United Kingdom.