Dr. Rassman, I have some questions about hair cloning and paritcularly about the company Intercytex which is working on hair multiplication. The company says they have completed phase 1 human safety trials and are going to began phase 2 human efficacy trials in mid-2006. They have also been quoted in newspaper sources as projecting that they will have a commerical product by 2010. I take this projection as a grain of salt as I did Ken Washenik’s projections circa 2003 which appears to have been incorrect, but I have some questions about the company and its developments. First, is the company legitimate? It is in a partnership with Johnson and Johnson so it appears to have some legitimacy, what do you think about the company? Second, is it significant that they are doing this in humans, it this a leap forward in the progress of cloning? I believe Aderans and other hair cloning research companies are still playing around with mice. Third, what do these phases mean? Are they part of the FDA approval process, for example is each phase required to follow FDA guidelines and then if the product makes it through all three phases is it then FDA approved, or does it have to go through an FDA approval process following its completion of the phases. Also, can you give some general comments on hair cloning. I know you don’t have a crystal ball and you are probably tired of this question, but how long do think it will be before hair cloning is an established medical practice, 10, 20, 50 years? Hair transplantation was first done in the 1950’s and it took 30-40 years before it became a safe, developed procedure. Do you think hair cloning will have the same kind of growing pains and take a similiar lenth of time to mature? Your answers to these questions would be greatly appreciated by myself and I believe many others. The internet hair loss community seems to be abuzz over this topic. Also, thank you for this blog!!
I have no particular inside knowledge about this company. I read the press releases just like everyone else.
To address your curiosity on phases for drug development and what it means, see: Phases of Product Development
Hair Cloning Timelines: In 1987, Dr. Colin Jahoda first cloned hair. When that happened, the excitement was wonderfully high and the entire world thought that the solution to cloning a human hair for clinical use was around the corner. The cloning worked in petri dishes, but when these cloned hairs were put into bald mice, the cloned hair killed the mice. Now, almost two decades later, we are really no further along. If you look at the drug development steps referenced above, it is important to note that this entire process runs about 16 years and that count is taken from the point where the drug or the approach is first put into the line. For drugs or solutions not yet identified, you must add this timeline of 15-16 years to the first identification of the substance. With the recent debacle just recently on a new drug (Parexel) that went into phase 3 clinical trials (Parexel in hot water) you can see how easily the solution can hit a snag and just how potentially dangerous this process is. For Parexel, it may spell disaster and this event may very well end its short life span. Unfortunately for the 6 people used in the study, their life span may also end with the drug’s life. Of importance, please note that this drug was for treating very disabling or deadly diseases, conditions including multiple sclerosis, rheumatoid arthritis, and leukemia. Hair loss in the classic sense, is neither deadly or painful so risks to protect the consuming public will have standards that are even harsher than with Parexel. As a consumer, we want to believe that miracles are around the corner, that cures for all ailments are within the grasp of modern medicine, but alas, reality is nowhere near our hopes and optimism on such issues. I personally do not believe that the safety issue can be resolved in anything less than 10 years, so do not hold your breath.