ICX-TRC HAIR REGENERATION: HUMAN CLINICAL TRIALS

ICX-TRC is an autologous (donor source is same as recipient) hair regeneration therapy intended for the treatment of male pattern baldness and female hair loss. Drs Farjo are the sole investigators in this trial, on behalf of Manchester-based Intercytex Group plc, since 2003. Success will promise potentially unlimited supply of donor hair for patients.

The Principle:

A small sample of hair follicles (similar to harvesting donor tissue for a hair transplant) is taken from the patient during a simple 30 minute operation carried out under local anaesthetic at the clinic. The tissue is sent to Intercytex’s manufacturing facility, where the hair-inductive dermal papilla cells are disassociated from the rest of the follicle. These cells are cultured and expanded in proprietary media over eight weeks and subsequently returned to the clinic in a sterile suspension. Using a specialised delivery system, the hair-inductive dermal papilla 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 dermal papilla cells capable of inducing new hair growth. Following the procedure, new hair growth should become evident after approximately three months.

Phase I clinical trials (safety) have been completed in seven volunteers at the Farjo Medical Centre. No safety issues have arisen and five out of the seven patients have shown increased hair numbers. We have commenced recruitment for Phase II clinical efficacy trial on patients with male pattern baldness, with an initial cohort of up to 20 subjects who will be followed by variations in delivery technique in further similar sized cohorts. The trial is designed to demonstrate efficacy of ICX-TRC, the dosage regime and the delivery device. Preliminary data from this trial phase is now available, however, a commercial product is not expected to be available before 2011.

Intercytex is developing a robotic system with The Automation Partnership for the commercial-scale production of patients’ autologous dermal papilla (DP) cells. The robotic system has an established track record in processing many different cell samples simultaneously. It is vital that at this scale, in which a large number of different patients’ cells are handled, that all samples remain isolated throughout the multiplication process. Intercytex was awarded a substantial UK government scientific grant in October 2006 for this purpose.

Latest Clinical Trials Update released on March 26th, 2009:

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 one 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 six 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.

Thirteen subjects completed the 48-week trial with six 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 was:

o    40% (n=6) for hairs of all sizes

o    18% (n=6) for hairs over 30 micron in diameter

The larger (900 injection) area photographs have not yet been analysed.

This data is consistent with the interim data reported last September and further confirms 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.

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 1000 of these injections in a relatively short period of time and with 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.”

More information is also published on www.intercytex.com

Sadly, mainly for financial reasons we had to abandon the clinical trial in the UK in 2009. The results of our work is contributing to ongoing trials in the USA, but there is nothing exciting to report yet.

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