US hair loss technology provider Kerastem has confirmed that patients who underwent the Phase 2 clinical trial in early-stage hair loss achieved an increase in mean terminal hair count in men with early hair loss when compared to the control group. Based on these results, Kerastem plans to begin a Phase 3 clinical trial later this year.
Kerastem therapy is a one-time treatment that delivers fat derived regenerative cells combined with purified fat to the affected area of the scalp, the company explains. The protocol for Kerastem uses the Puregraft system for obtaining a purified autologous fat graft.
The Phase 2 trial, referred to as the STYLE study, was a US 70 patient multi-centre, randomised, single-blinded and controlled trial to assess safety, tolerability, dosing and hair counts in patients with early hair loss.
Keratsem reported that the low dose adipose derived regenerative cells (ADRCs) and Puregraft fat treatment group, compared to the control group, achieved an average increase of 29 terminal hairs per cm2, corresponding to a 17% increase.
Brad Conlan, CEO of Kerastem, commented, “Our Phase 2 study showed that the treatment stimulates hair growth in early stage male hair loss. If our Phase 3 trial is successful, more than 40 million people in the US with early stage hair loss would have a new option.”