Intercytex Phase II Cell Therapy Research Trial Completion Data
26th March 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 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 was
- 40% (n=6) for hairs of all sizes
- 18% (n=6) for hairs over 30 micron in diameter
The larger (900 injection) area photographs have not yet been analysed.
These data are consistent with the interim data reported last September and further confirm 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 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.”
Further results of the trial will be presented later in the year.
More information is also published on www.intercytex.com