Photo Credit: kerastem.com
Injections of stem cell-enriched fat may help reverse hair loss.
At least that is what an active US Food and Drug Administration (FDA) studyÂ of the Kerastem Hair Therapy hopes to show. The treatment is already CE mark approved for people with hair loss outside the United States.
Hair transplants and other treatments that promote hair regrowth or stop hair loss do exist, but each available method has its share of risks and downsides. Stem cell-based treatments like Kerastem Hair Therapy, if validated, may be game changers for the close 80 million people in the US with hereditary thinning or baldness.
The term â€˜stem cellâ€™ and â€˜stem cell cureâ€™ are bandied about, and there has been some concern that hucksters would prey on the ailing and desperate â€“ promising that these are the antidotes to many a medical condition or disease.
Stem cells are precursor cells that are believed to morph into blood, brain, bones and all of your organs. The FDA cautions us all to make sure that any stem cell treatment has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.
Kerastem falls into the latter camp.
Jeffrey S. Epstein, M.D., FACS, Founder and Director of the Foundation for Hair Restoration and Plastic Surgery in Miami and New York City, is one of the investigators in the U.S. trial of Kerastem, which will take place across several sites. He is now recruiting 70 individuals with moderate male- or female-pattern hair loss, who have not had prior hair transplant surgery or received medical therapy to reverse hair loss for the past 6 to 12 months. The Â â€œSTYLE Trialâ€ should be completed by June 2017.
â€œThe protocol involves harvesting fat from one part of the body and then processing and preparing it with the Celution and Puregraft Systems for re-injection into a specified area of the scalp,â€ he says. â€œThereâ€™s speculation that the fat will increase vascularity,â€ or blood circulation to hair follicles, which will encourage growth. â€œItâ€™s already being done in Europe and I am eager to see how it works,â€ he says. “In the future, it may be used as a standalone treatment or even with existing hair loss treatments to enhance their results.”
So far, the data from abroad look pretty good. In an initial clinical series from the UK, investigators performed a single scalp injection of Kerastem in 9 healthy hair loss patients, and a total of 6 patients were followed for a period of six months using objective measures to quantify hair growth. The authors reported a 100% patient response rate to the Kerastem Therapy at 6-months and in patients with early stage hair loss, the percentage increase in hair count/density was a mean difference of 17%. In males with early grade loss, an average 29% increase in hair count/hair density with a mean difference of 40 hairs per square centimeter was observed.