Enrollment has now officially closed for volunteers wanting to take part in the phase II clinical STYLE trial, investigating treatment for early stage genetic hair loss
Cytori Therapeutics, Inc. made the announcement on behalf of its licensee, Kerastem Technologies, LLC, from which the liposuction-based treatment derives its name.
“Cytori Cell Therapy is a broadly applicable cell therapeutic platform used now in multiple mid and late stage clinical trials in the US, Japan and Europe. Our partner Kerastem is focused on developing Cytori technology for men and women with alopecia
,” said Dr. Marc H. Hedrick, President & CEO of Cytori. In this instance 'alopecia' refers to androgenetic alopecia - Male Pattern Baldness
and Female Pattern Hair Loss
, rather than the autoimmune disorder Alopecia Areata
which also causes hair loss.
involves the patient having small amounts of fat (adipose) removed from their hip area using a minimally invasive liposuction technique. After this, stem cells are taken from the collected adipose and enriched. The resulting solution is then injected into the patient's scalp.
The process is similar to that used in PRP
, however, in PRP it is blood that is taken and enriched via a centrifuge before being administered to the scalp via injection, rather than adipose.
Further exploring early findings
The new STYLE trial
is a phase II randomized, blinded, and controlled investigation of Kerastem therapy in men and women in the early stages of genetic hair loss
. One of four different treatment options, including a control, will be randomly assigned to each of the volunteers.
It was expanded to take part in four different trial sites across the USA and will assess 70 patients in total. The primary objective of this clinical trial is to establish Kerastem's safety and tolerability in these volunteers at six months and 12 month intervals.
Cytori's Dr. Hendrick noted, “Early proof of concept clinical data has shown promise and Kerastem expects a read out from the trial in approximately one year.
Despite the on-going research trials, Kerastem therapy is already available in Europe & Japan, and is looking to expand into America and the UK. Whether it will prove to be effective as a treatment in its own right, or - as with PRP - simply useful as a hair growth booster
alongside proven treatments remains to be seen.
It is also up against existing MHRA licensed and FDA approved hair loss treatments
which have been clinically proven to treat male and female pattern hair loss effectively. These have the benefit of also being widely available, as are the various hair growth supporting products
which can be used to supplement this non-invasive approach.