KERASTEM HAIR THERAPY
CLINICAL
PIVOTAL
AVAILABLE
UNITED STATES
CE MARK COUNTRIES (i.e. Europe)
JAPAN
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.
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)
No fat 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.
androgenetic alopecia (AGA)
Androgenetic alopecia(AGA)¹,² is the most common form of hair loss in both men and women. This condition is also known as male or female pattern baldness. In men, hair is lost in a well-defined pattern, beginning above both temples. Over time, the hairline recedes to form a characteristic “M” shape. Hair also thins at the crown (near the top of the head), often progressing to partial or complete baldness. The pattern of hair loss in women differs from male-pattern baldness. In women, the hair becomes thinner all over the head, and the hairline does not recede. In the United States alone, approximately 80 million men and women suffer with this condition.
¹U.S. National Institutes of Health (Genetics Home Reference)
²American Academy of Dermatology