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 a history of success in treating genetic hair loss. High strength minoxidil, a highly effective topical treatment that is applied directly where it is needed on the scalp, can be used by both men and women, whilst the daily tablet Finasteride 1mg is an added option for men only and compliments the action of the minoxidil.
These medications can be used alongside a range of boosters and these types of courses have continually produced a number of impressive regrowth results for some of Belgravia’s male and female hair loss clients over the years.
The Belgravia Centre
The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. 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 UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.