I read an article in the LA Times dated April 17, 2006, about the haircloning process. In your opinion, when will the hair cloning process be available to the public. Are you involved in the research of the hair cloning process?

Thank you for your time and consideration.

Almost every day, I get some form of this question. Sometimes they get posted here, sometimes I just reply with a link to the Hair Cloning category. The idea that hair cloning is around the corner has no basis, yet the rumor persists. I do not believe that we will see anything for a good 5 + years, maybe 10 years or something between. I stay right up front in this process and stay in touch with everyone doing the various types of research. This is not a recreational activity for a good solid researcher.

Most people in the know believe that Drs Walter Unger and Jerry Cooley have stood at the doorstep for the emerging arena of hair regeneration. They have both spoken at various medical meetings on the subjects of hair regeneration and hair cloning and they have been kind enough to comment on the history and status of the field. Included are comments on the company Intercytex from England, the company which has generated a great deal of hype and excitement in the field today, the company I have previously commented on in various postings.

The following segment is written by Walter Unger, M.D.

Having been a consultant for various medical investigations over the years, I know that companies can misrepresent, in a variety of ways, the results of studies and your collaboration with them. We therefore shouldn’t think of the company’s promotional statements as necessarily scientific or formulated/agreed to by the medical consultants that are working with them. Some doctors also use exaggerations in their own promotional material so we probably shouldn’t be too harsh about a company’s promotional zeal.

To put in perspective the results of this company and others it may be worthwhile to remember: when I was doing the cell therapy studies, we could successfully grow the hair follicle cells that we were interested in, in 100% of the cases, growing millions of cells from a single cell with no problem at all. We also could successfully transfer those cells into athymic mice and in almost 100% instances, grow hair on the mice. I was very excited when we got to that stage because I thought for sure we could use the same cells in the human donor and grow hair on them if we could grow their hair on the mice. In fact this didn’t happen; we grew hair on 1 of the first 10 patients and 3 of the 13 in the second study. But the numbers of hairs and quality of hair was not nearly as good in the second group as in the first. It was at that point that we ran out of funding as the sponsor took ill and ultimately died from that illness. What I’m trying to say and what I think most investigators in this field will agree with is that it’s a huge step from laboratory studies to actually getting consistent hair growth in a human. There is some missing factor or factors. I’ve concluded that this project will require some luck rather than just knowledge and hence my relative disinterest in doing further studies at this time.

The following segment is written by Jerry Cooley, M.D.

“I have worked with Intercytex for the past five years. Everyone I’ve met from the company seems very reputable and has a sterling reputation; their staff includes almost 50 at this point and they’re very well funded. They have projects going for skin substitutes, soft tissue augmentation, and even renal failure. By the way, I am not a spokesman for Intercytex and have no equity in the company. My role is to offer clinical input for their product development.

A multitude of labs have consistently regenerated hair follicles in animals and there have been a scattering of reports in humans–Colin Jahoda, myself, Aderans, Walter Unger, PheonixBio in Japan, etc. There is a wide gulf between animal research and human experiments at this point in time. But that’s pretty typical for the biotech pipeline. That animal research is making definite and exciting headway, for example in showing that ‘cloned’ hair does cycle, and that multiplications of 100 fold are possible from third passage cultured human Dermal Papilla cultures.

Not being directly involved in running a biotech company, I can only imagine that there is tremendous pressure on these people to generate media coverage for their ventures to keep the public and especially investors interested. You don’t get very far by telling reporters, “I’m not really sure how all this is going to turn out”. Many pioneers in surgical procedures created exuberant publicity for their techniques even before they were perfected, and it often had its unsavory aspects. Nevertheless, that publicity led to greater public interest and ultimately acceptance of follicular unit transplantation and megasessions. Perhaps we will see the same pattern play itself out with cell therapy.

I agree with you that cloning is not going to be available anytime in the immediate future, but why do you say 10 years just for safety issues? According to Intercytex, they have already completed the phase I safety trial. Also, isn’t the fact that scientists have successfully transplanted hair into mice and are now putting it into humans a breakthrought? According to Intercyted Seven human individuals from phase I trial currently have “cloned” hair on their heads. Isn’t that pretty huge?

If a doctor thinks that he can find a stem cell on you and move it to your head in the hope that it will grow hair (it actually might) then the doctor may be allowed to do this if he does this in his office. He has to pay attention to the medical licensing board’s rules on human experimentation, but he will not be going through a hospital-certified facility.

If he takes something out of your body (or even worse, from a mouse as you suggest) and then does something to it, following that by reinjecting it into you, then he is using a ‘drug’ which would then be covered under FDA regulations. Safety and effectiveness for a drug takes many years (15 on average) and cost about $800 million. Thousands of people must be tested and safety and effectiveness must be confirmed according to FDA rules and under FDA guidance. That is why I said 10 years. A cloned mouse hair on a human head fits that timeline for me, but if that happens on your head, be sure to stay away from cats.

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.

Sir, Can you please comment on this:
‘Auto-cloned’ beard hair viable alternative donor source for transplantation

I caught this presentation at a meeting of the ISHRS about 2-3 years ago. I was very impressed with the idea, but the proof was severly lacking with a minimal number of patients presented. Based upon hearing the presentation, Dr. Robert Bernstein and I decided to repeat the process on a few human volunteers. The process failed to work in our hands.

Considering that this doctor has been doing this now for a few years and only 5 patients were shown without publication in a peer review journal, I would look at the study with a jaundiced eye. I tend to believe less of such claims when there is no proper documentation or a good research study based upon good scientific methodology. The world is still rebounding from the Korean debacle for cloning and it shows two things: (1) we are gullible because we want to believe that cloning or this type of ‘free’ hair is something we all can have, and (2) honesty is always the best policy. To date, hair cloining is in its infant stage and there is no guarantee that the industry will develop along the lines of any particular investigator’s approach.

Do you think NHI will ever perform hair cloning procedures?

When cloning is a safe and proven method for restoring hair, we will be on the forefront of it. It will take years and years for the FDA to approve the defined process of cloning and that process has not yet been defined. I don’t hold my breath waiting.