Hair loss Facts.Hair loss affects approximately 40% of men and 20% of women aged 50 and over. In the US there are an estimated 40 million men and 12 million women suffering from some degree of baldness. The estimated market size for hair regeneration products and treatments is over $1 billion for both men and women but only 2% of patients suffering hair loss currently seek any treatment.
Existing Treatments.
Hair loss treatments available today a few and far between, so far there is only two medicines which have been licensed for use as a Male hair loss product. 1 Propecia & 2 Regaine.
Propecia is the more successful treatment out of the two and has many papers and happy customers that have used the product who have either stop hair loss in its tracks or regained lost hair.
Regaine can be bought over the counter at most pharmacies & supermarkets and has worked on a smaller percentage to some degree.Hair Cloning
But now a company in Manchester called Intercytex have been busy working on cloning, hair cloning that is. Already phase 1 & 2 of the hair cloning trials have been completed and are showing some promising results.
The ICX-TRC procedureA small sample of hair follicles is taken from the patient during a simple 30 minute operation carried out under local anaesthetic at a hair or skin clinic. The clinic sends the biopsy to Intercytex’ GMP compliant manufacturing facility where the DP cells are dissociated from the rest of the follicle. These cells are cultured and expanded in proprietary media over three weeks and subsequently returned to the clinic in a sterile suspension.sing a specialised delivery system, the DP cells are microinjected intradermally into the patient’s scalp. The treatment is performed under local anaesthetic and comprises a single procedure of superficial injections, each injection delivering a minute volume of media containing DP cells. These cells are able to stimulate the generation of new hairs when injected in close proximity to the epidermal cells which generate the hair. Following the procedure, new hair growth should become evident after approximately three months.ICX-TRC clinical and commercial developmentPhase I clinical trials (safety) have been completed in seven volunteers at a single UK transplant centre. No safety issues have arisen and five out of seven patients have shown increased hair numbers. A Phase II study, which was conducted by Dr Bessam Farjo in Manchester, is now complete. This trial was designed to examine the effect of different DP delivery techniques and methods to ensure that the epidermal cells were in the correct state to respond to the signals and produce new hairs.In this study, subjects were injected 900 times with 1µl aliquots of DP cells in a large area which was photographed at the end of the study. Subjects were also injected in a smaller area, divided into two sections - counts were obtained by shaving and photographing the two small sections of scalp, injecting them multiple times (either 1 injection of 50 µl or 50 injections of 1 µl) with living DP cell suspension and then applying a specialised image analysis system to provide a total hair count. In these small sections, all 19 subjects in the trial were treated using a range of injection and scalp pre-stimulation techniques; the first 6 subjects were injected without stimulation of the scalp. In the remaining 13 subjects the resident hair producing (epithelial) cells were stimulated at the time of delivery of the DP cells in one of the two treatment sites.13 subjects completed the 48-week trial with 6 subjects lost to follow-up. Of the 13 subjects completing the trial the data showed that:• 65% (11/17) of the treated sites in the non-stimulated group responded to the treatment by increasing numbers of hairs of all sizes• 71% (12/17) of the treated sites in the non-stimulated group responded to the treatment by increasing numbers of hairs over 30 micron in diameter• 78% (7/9) of the treated sites in the stimulated group responded to the treatment by increasing numbers of hairs of all sizes• 100% (9/9) of the treated sites in the stimulated group responded to the treatment by increasing numbers of hairs over 30 micron in diameter• The overall take rate (number of hairs produced per 100 injections) in the stimulated areas waso 40% (n=6) for hairs of all sizeso 18% (n=6) for hairs over 30 micron in diameter
The results of these trials are a big leap in finding a permanent cure for hair loss.
Dr Bessam Farjo, the Principal Investigator for this study, said “We have learned a lot from this trial, including the different ways in which these cells can be delivered and that it is possible to do one thousand of these injections in a relatively short period of time and at little discomfort to the patient. I am very encouraged by this data both in the increase in the total number of hairs in the treated site but more importantly by the increase in thicker hairs, those over 30 micron.”
