Intercytex Products page for ICX-TRC - hair regeneration update/changed today
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.