Hair Loss Treatment Has Arrived with Follicular Cell Implantation
Stem cells and dermal papilla cells have been discovered in hair follicles and some researchers predict research on these follicular cells may lead to successes in treating baldness through hair multiplication (HM), also called Hair Cloning.
Hair Cloning is being developed by two independent companies: ARI (Aderans Research Institute, a Japanese owned company in the USA) and Intercytex, a company in Manchester (UK).
On October 2006, Intercytex announced they have successfully tested a method of removing hair follicles from the back of the neck, multiplying them and then reimplanting the cells into the scalp. The initial testing resulted in 70% of male patients regrowing hair. This treatment method is expected to be available to the public by 2010.
In June 2008, Intercytex announced positive results of their Phase II trial for a form of cloning based Hair multiplication technique called follicular cell implantation. The treatment is being hailed as a major advance in hair restoration and is backed by a £1.9 million government grant. The treatment is predicted to be available to patients within 5 years. In the company’s own words:
We have now completed the treatment phase of our Phase II study, being conducted by Dr Bessam Farjo in Manchester, to optimise the delivery of the DP cells.
In this study, hair counts are obtained by shaving and photographing a small section of scalp, injecting it and then applying a specialised image analysis system to provide a total hair count. All 19 subjects in the trial have now been 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 the resident hair producing (epithelial) cells were stimulated at the time of delivery of the DP cells.
11 subjects have now passed the 24-week time point since treatment and specialised image analysis at this time point showed:
• Of the group of 6 patients without stimulation of the scalp, 3 had an increased hair count and
two had a reduced hair count; one has been lost to follow-up.• Of the 5 subjects with pre-treatment scalp stimulation, all had increased hair count at 12 weeks and the 3 who were evaluable at 24 weeks all had an increased hair count at that time point.
These data are consistent with the earlier data reported last September and the hypothesis that new hair production is improved by pre-stimulation of the scalp, leading to an interaction between the injected cells and the resident hair producing cells.24 week data on all subjects in the trial will be available in September 2008 and at the end of the trial photographic data will be analysed from a much larger area of treated scalp on all subjects at 48 weeks.
ICX-TRC overcomes one of the principal drawbacks of conventional transplants which is that the outcome is limited by the amount of donor hair available. By using the Intercytex cell therapy technique almost limitless hair regeneration is possible in a less invasive procedure. Furthermore, treatment can commence early on in the hair loss process with retreatment available in subsequent years. The barrier to commercial success for ICX-TRC is relatively low, being the ability to increase hair count in transplanted or thinning areas.
We believe the continued development of ICX-TRC would best be carried out in partnership with a specialist in the aesthetics field. We do not intend to finance the continuation of clinical and commercial development of ICX-TRC beyond the current Phase II trialand shall seek to sign a partner when we have the complete data package from this trial. Intercytex has granted Bosley, the largest chain of hair transplant clinics in the US, an option to negotiate distribution rights to the product.
Intellectual Property
We have split our cell delivery patent application into three separate applications in the US reflecting additional techniques that are being developed. We have also filed a patent application relating to our observation that epidermal stimulation pre-treatment appears to enhance hair follicle formation.
Two other previously filed patent applications relating to the method of culturing the dermal papilla cells have been published and are undergoing international examination.
