Following on from the news last summer that it had won FDA approval for a Phase II clinical trial (named “STYLE”), Kerastem Technologies has announced it is extending the number of test centres where people with hair loss can participate.
With trial sites in Los Angeles and Miami previously announced, the company said this week that they have now added New York and New Jersey to the list. The FDA application allows for a maximum of eight centres within the United States.
Driving hair growth therapies
Kerastem Technologies is owned by Bimini Technologies and is a partner of a company named Cytori Therapeutics. On the Kerastem website, the company explains that they have a “focused US FDA Clinical Trial Strategy to enable driving hair growth therapies to market.”
The Kerastem Hair Therapy treatment programme is currently CE mark-approved for patients with genetic hair loss (more commonly referred to as Male Pattern Baldness and Female Hair Loss), and is currently available in Switzerland, Spain and Japan. Outside of the US clinical trial, it is not currently available in America.
While the company’s approach to treating hair loss is certainly different to that of many others, it is not entirely unique. Like PRP therapy (Platelet Rich Plasma), the Kerastem method extracts and enhances substances already found within the body before re-injecting them where they are needed – specifically in the scalp. In the case of PRP, it is a patient’s blood that is modified. With Kerastem, it is stem cells from fat.
Cytori state that: “Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy may provide benefits across multiple disease states.” They add that Kerastem holds global rights to commercialise Cytori Cell Therapy for alopecia and hair-related indications.
“Kerastem is dedicated to bringing Cytori technology to market for men and women with alopecia,” says Dr. Marc H. Hedrick, President and CEO of Cytori. “The Kerastem team has assembled an excellent clinical team. If this trial is successful, we believe the Kerastem/Cytori partnership could provide effective treatment for people dealing with hair loss.”
Hair regrowth success
The STYLE trial will involve up to 70 patients, a mixture of men and women, all of whom exhibit either Female Pattern Hair Loss or the early signs of Male Pattern Baldness.
The doctors involved expect to finish the trial this summer. After that, the results will be analysed and findings announced before it is decided which further tests are needed to ensure the treatment’s safety and efficacy.
New hair loss treatments can take many years – decades, even – to become available as there are a number of strict criteria they must pass first in order to prove that they are both suitable and worthwhile, examining side effects, any age restrictions or medical conditions which may exclude users from using the product.
In the meantime, there are FDA-approved and MHRA-licensed products available now which have been proven to treat genetic hair loss in men and women. These medications can be used alongside a range of supplementary products and a consultation with a hair loss specialist can help those worried about losing their hair to navigate the choices available including recommending those best suited to their condition and medical suitabilities.
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.