Kerastem is a hair loss therapy, currently under development, in which autologous stem cells, derived from the patients’ own adipose (fat) tissue, form the basis of a treatment for common genetic hair loss (androgenetic alopecia). ((Kerastem: Advanced Hair Therapy. http://kerastem.com/.)) It is thought that the stem cells work to repair or replenish the “follicular niche” around dormant hair follicles, and this may lead to the regeneration of healthy hair-producing follicles.
Kerastem Hair Therapy will primarily be marketed to female patients due to the relatively limited number of effective hair loss treatments for women, but it is also being tested in men. The preliminary phase of Kerastem clinical trials is complete, and the Phase II trial; designed to test the safety, tolerability, and efficacy of the treatment; is underway. Phase II is set to conclude in December 2016.
The Kerastem Procedure
Kerastem is a not a hair loss medication or topical product, rather it is a therapeutic procedure that uses autologous tissues (i.e., tissues collected from the patient) to create the treatment on a patient-by-patient basis. The Kerastem procedure entails three basic steps:
- Extraction
- Laboratory processing
- Delivery of treatment into the balding areas of the scalp
Step 1: Extraction of Tissue
Adipose (fat) tissue from a patient’s waist area is extracted via micro-liposuction.
Step 2: Laboratory Processing
The adipose tissue is “purified” using the Puregraft System; a process that removes excess lipids, oil, and damaged blood cells leaving pure adipose tissue. The Celution System is then used to prepare adipose-derived regenerative cells (ADRCs) from the fat tissues. The purified adipose is then “enriched” with the ADRCs to form the basis of the treatment.
Step 3: Delivery of Treatment to Scalp
The purified, “enriched” adipose tissues are injected into balding areas of the scalp to potentially induce hair follicle regeneration.
Trials
Kerastem Hair Therapy is currently in Phase II of trials designed to investigate the safety and efficacy of the treatment in men and women with androgenetic alopecia. The trial is randomized, double-blinded, and placebo-controlled, and it involves 70 participants split into 4 arms. The first arm will receive injection of the purified adipose plus a “high dose” of 1,000,000 regenerative cells. The second arm will receive injection of the purified adipose plus a “low dose” of 500,000 ADRCs. The third arm will receive injection of only the purified adipose cells. The fourth arm will receive injection of only saline solution.
The outcome is expected to supplement findings from a small-scale Phase I study that reported a 100% “patient response rate” at six months in the six patients who received Kerastem treatment in London, United Kingdom. In Phase I, patients with early stage hair loss saw a 17% -29% increase in hair density. ((“Kerastem Hair Growth Data Presented At 2015 International Society of Hair Restoration Surgery (ISHRS) Annual Scientific Meeting.” PR Newswire. http://www.prnewswire.com/news-releases/kerastem-hair-growth-data-presented-at-2015-international-society-of-hair-restoration-surgery-ishrs-annual-scientific-meeting-300140941.html.))
Kerastem, Stem Cells & Hair Cloning
Stem cells are considered the holy grail of regenerative medicine due to their pluripotency (i.e., their potential to morph into any cell type). For this reason, studies have attempted to manually induce stem cells to differentiate into the tissues they are intended to repair or replace. One such area of study is hair cloning or hair multiplication. In this concept, hair follicle stem cells are harvested from the patient, cloned (multiplied) in a laboratory, and then implanted in the balding areas. It has long been theorized that hair cloning research may yield a procedure that would eliminate the need to surgically harvest thousands of hair follicles from a person’s scalp. Despite considerable promise and progress, no such treatment has yet been developed.
The Kerastem therapy works on a very similar principle as hair cloning, with the exception being that the regenerative cells are harvested from fat tissues and not from existing scalp hair follicles. It remains to be seen if Kerastem can be considered viable in the long-term or if it too will run into practical hurdles that prevent it from supplanting traditional hair transplant methods.
Conclusion
The relationship between populations of stem cells in the scalp and the formation of hair-producing follicles is complex. The current research is another attempt at understanding this relationship by investigating fat cells and their role in triggering the hair growth cycle. According to preliminary findings, Kerastem may be an effective treatment option for androgenetic alopecia in men and women. While Phase II testing will help determine efficacy of the treatment, additional independent research is needed to confirm this and to assess efficacy over the long-term.
