The FDA has granted Kerastem Technologies conditional approval to conduct a clinical trial into the safety and feasibility of its technology designed to treat androgenetic alopecia, more commonly known as male and female hair loss.
Kerastem Technologies is privately owned by Bimini Technologies, a company known for its Cytori Therapeutics hair loss products and being a leading fat-graft technology provider.
Kerastem currently produces a treatment for androgenic alopecia, known as Kerastem Hair Therapy, which is currently available only outside the USA, in Switzerland, Japan and Spain. This product bears the CE mark – a European health and safety regulation compliance sign – but is not currently FDA or MHRA approved.
According to the company’s website, it works by extracting stem cells from tissue taken by liposuction from the person’s hip area. These stem cells are then added to Puregraft fat from the parent company, in order to produce ‘enriched fat’ which is then injected into the scalp. This is believed to promote regrowth in areas of thinning hair caused by genetic hair loss.
Addressing female and ‘early’ male hair loss
Women with hereditary hair loss tend to experience localised thinning across the top of the scalp – the area affected by the DHT that causes genetic hair miniaturisation – but do not tend to go completely bald.
Men, however, can show a number of signs of hair loss, – also located around the top of the head – including a receding hairline or a thinning crown, which, if left untreated, can deteriorate until the scalp takes on the shiny appearance associated with baldness, meaning that the hair follicles have died. As the action of hair loss treatment is to stimulate the hair follicle into producing hair growth, if the follicles die, treatment is futile.
Phase II STYLE trial
Kerastem announced the news via a press release, detailing how the FDA Centre For Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies has granted them this approval for a phase II study into the hair loss treatment, which they are calling the ‘STYLE trial’.
Enrollment for this clinical trial, which will take place across up to eight test centres around the USA, will begin in late 2015, and a total of 70 patients will be studied. The company states that its primary aim for the trial is to ensure ‘safety and tolerability of the treatment’. Its secondary goal is to show that the treatment can demonstrate ‘change in hair growth and density’.
“I have been heavily involved in the care and research of alopecia patients and treatments for over 20 years, including the use of cellular based approaches,” says principal investigator Ken Washenik, MD, PhD, Medical Director–Bosley Medical Group, and Clinical Assistant Professor, Department of Dermatology, NYU School of Medicine, “As principal investigator of the STYLE trial, I look forward to evaluating this exciting new approach to the treatment of hair loss.”
The trial has now been officially registered with the official clinicaltrials.gov website for those who wish to track its progress.
Initial data to be unveiled in September
“The hair market has few acceptable solutions for early hair loss, particularly in women,” said Bradford Conlan, CEO of Kerastem. “STYLE represents a defined clinical pathway in the United States and complements our commercial efforts in Europe and Asia.”
Findings from the precursor to the STYLE trial, initial clinical studies carried out in Europe and Japan, are due to be presented this September in Chicago at a meeting of the International Society of Hair Restoration Surgery. Then, once the STYLE trial is concluded, these results will then form the basis of a submission for FDA approval.
There are, of course, already two clinically-proven hair loss treatments available that are approved by both the MHRA in the UK and the FDA in America.
The Belgravia Centre is an organisation specialising in hair growth and hair loss prevention with two clinics and in-house pharmacies in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the world. View our Hair Loss Success Stories, which includes the world’s largest gallery of hair growth comparison photos and demonstrates the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time to arrange a free consultation.