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intercytex old news?


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Read the last paragragh. It says that the data will be available september this year. Might be old news i dunno???

 

 

 

The ICX-TRC procedure

 

A 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.

 

 

 

Using 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 development

 

 

 

Phase 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.

 

 

 

The treatment phase of a Phase II trial, being conducted by Dr Bessam Farjo in Manchester, to optimise the delivery of the DP cells, has been completed.

 

 

 

In this study, hair counts were 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 six 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 six patients without stimulation of the scalp, three had an increased hair count and two had a reduced hair count; one has been lost to follow-up.

 

 

 

?· Of the five subjects with pre-treatment scalp stimulation, all had increased hair count at 12 weeks and the three 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.

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