Kerastem Technologies to conduct trials to treat pattern baldness

Kerastem Technologies has secured conditional approval from US Food and Drug Administration (FDA) to conduct a clinical experiment to evaluate the safety and feasibility of its solution to treat male and female pattern baldness.

The company has so far performed 21 procedures at four trial sites in the US as part of the phase II STYLE trial that included fat harvest from small volume liposuction and scalp injections.

The phase II STYLE trial will involve the evaluation 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 male and female hairloss.

Kerastem Technologies chief medical officer Dr Eric Daniels said: "We are very pleased by the study progress and the commitment of our study centers to the STYLE trial.

"In addition, we are encouraged that we have been able to demonstrate that same day fat harvest, cell processing and scalp injection is feasible and has been performed safely in multiple US centres.

The Kerastem’s phase II trial will be undertaken as a controlled investigation of Kerastem therapy in early stage female and male pattern baldness.

With the approval, the company will conduct tests on roughly 70 patients at eight centres within the US.

The trial is scheduled for completion later this year.