Intercytex phase II hair multiplication trial update
Note: there are new results in this trial. See the March ‘08 Intercytex update here
Intercytex, a UK-based biotechnology company, released the results from their ongoing ICX-TRC Phase II trial hair multiplication technology today.
To be clear: permanent hair is being grown on bald scalps. No drugs or further treatment is needed to keep the hair. This is the beginning of an absolute cure for hairloss.
From the PDF information sheet:
ICX-TRC consists of a suspension of autologous dermal papilla (DP) cells. These cells are able to stimulate the generation of new hairs when injected into the scalp in close proximity to the epithelial cells which generate the hair. The purpose of the ongoing Phase II study being conducted by Dr Bessam Farjo in Manchester is 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. Two sub-groups were each injected with autologous DP cells using different delivery techniques. The first group focussed on delivery of the hair inductive DP cells, and in the second group resident hair producing (epithelial) cells were also stimulated at the time of delivery. Although it is too early to determine fully the differences between the sub-groups, the preliminary data are encouraging. In the first sub-group 2 patients out of 5 showed substantial increases in hair count (21 & 55%) at 24 weeks. In the second sub-group (5 patients in total) injected more recently, all patients showed substantial and visible increased hair counts at 6 and/or 12 weeks (13-105%). We believe this increased hair production is attributable to the interaction between the injected DP cells and the stimulated resident hair producing cells. A further 8 subjects will be treated with variations in delivery technique. The full data set on all subjects at 24 weeks will be available in the middle of 2008. This detailed analysis will form the basis of further Phase II or Phase III trials as appropriate. At the end of the trial photographic data will be analysed from a much larger area of treated scalp on all subjects at 12 months. Currently 2 patients have been lost to follow up.
What this means:
- There was a large variation in result quality, coinciding with Intercytex refining their technique.
- Everyone that completed the trial grew hair.
- Some patients doubled their hair count in the test area (105%). Other patients, not so much (13%).
- A new trial with 8 patients will begin soon, the delivery technique will be further refined.
- New results will be released in 24 weeks (mid 2008), with images.
- There may or may not be more Phase II or Phase III testing after this.
What we still don’t know:
- The quality of the new hair
- If repeat injections in the same area would yield continual improvement
- What “pre-stimulation” means, which by their account improves efficacy and is the basis of the second leg of their Phase II trial.
- If this new hair is definitely DHT resistant and cycles normally (Likely, but not proven).
So when will this thing come to market?
Depends on how the next leg of the trials go, but Intercytex already has a market-released cosmetic product called ICX-RHY which was greenlit by MHRA, the medical regulatory agency in the UK. It’s quite possible that our beloved hair multiplication technology will receive the same push to market after Phase II.
That said, ICX-RHY may have only made it to market because it’s a new technology that isn’t adequately regulated. There’s a big party-crashing cloud coming in the form of new European legislation called Advanced Therapies Medicinal Products Regulation (ATMP) , which may become law in 2008. This could be seen as either an extra hurdle or as incentive for Intercytex to get to market fast, as any existing approvals will not face the new regulation. (source)
Regardless of any setbacks, when the doors do finally open to a renewable source of hair, you can count on a stampede of bald man-mastodons rattling windows and flattening all life in a mad dash to the lab, wherever that may be. I’ll be the third formerly wooly mammoth from the front.
Read more: Hair Multiplication on the Tressless Wiki
