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Bosley Medical
Beverly Hills
9100 Wilshire Blvd.
East Tower Penthouse
Beverly Hills, CA 90212
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Follicular Neogenesis Research:
In-depth Interview with Ken Washenik, M.D., Ph.D., Chief Medical Officer of Bosley Medical
We are pleased to announce that Dr. Ken Washenik has met with representative from HairSite for an in-depth interview on May 30, 2003.
Ken Washenik, M.D., Ph.D., is the Chief Medical Officer of Bosley Medical Institute and Bosley Medical Group. Dr. Washenik is currently directing Bosley Medical's hair-related research initiative. This research effort will focus on all aspects of hair follicle growth and development, but will have as its primary emphasis the tissue engineering aspects of hair follicle induction and neogenesis.
The entire interview lasted almost three hours at Bosley Medical's Manhattan (NY) office. Dr. Washenik was very gracious and generous with his time. He addressed all the important questions raised in HairSite's Hair Multiplication Forum by our readers and most important of all, Dr. Washenik offered our readers the latest update on the timeframe issue.
We wish to thank Dr. Washenik and Bosley Medical for accommodating our interview request and we also wish Aderans much success in their research.
# 1 Hairsite: It has been over a year since you joined Bosley Medical. Can you tell us how you feel being the Chief Medical Officer for the largest hair transplantation practice in the world? Are you happy with your career decision to leave NYU?
Dr. Washenik: I am very happy with my career decision. I still maintain my academic ties with NYU so from a clinical standpoint as well as the research and academic standpoint, this has been a win-win situation for me. Bosley Medical gives me the ability to effect change in the hair industry much quicker. In less than two years, we have put together Aderans Research Institute, opened two research facilities in the U.S and assembled a team of highly respected scientists who are working full time on the next breakthrough in hair restoration. It would be difficult to accomplish all that just based on grant money alone from the university. Aderans is truly a large corporation whose core competence is all about hair. I would not have been able to make such an impact on the industry in such a short period of time had I not joined Bosley Medical. I am very thrilled with my experience.
#2 HairSite: You mentioned your academic affiliation with NYU, so what are some of the projects are you currently working on?
Dr. Washenik: Individual projects are still under confidentiality arrangement. But to give you an idea of the broad categories, one area is the use of biologics or immune response modifiers that have been recently approved by the FDA for psoriasis as a possible treatment for alopecia areata. Alopecia areata is an area that I am very passionate about and I hope that with the help of the National Alopecia Areata Foundation and my academic ties with NYU, we will make some progress for alopecia areata patients soon.
#3 HairSite: What is the official name for this new hair restoration technique that Aderans Research Institute is currently researching? Do you call it "Hair Multiplication", "Hair Cloning" or something else?
Dr. Washenik: People sometimes refer to the technique as hair multiplication or hair cloning. Technically, we call it follicular neogeneis, or hair follicle neogenesis. But "neogenesis" is such a tiresome word that we usually end up calling the technique hair multiplication or hair cloning. Bear in mind that hair cloning is a misnomer because in reality there are no fetal stem cells or embryonic tissues being used. We are not trying to grow hairs in the lab and put them in the scalp. When some people hear hair cloning, they think there is a dishful of individual hairs already formed in the lab and ready to be used on the scalp. That is not the case here. What we are trying to do is to generate what I call "hair seeds" and then plant them into the scalp to grow new hair.
#4 HairSite: It appears that Aderans Research Institute (ARI) has two groups, one in Atlanta and the other in Philadelphia. Can you tell us what each of the two groups is responsible for?
Dr. Washenik: The two groups within ARI focus on different areas of the same research - tissue engineered hair growth. In its simplest form, we have a research group in Philadelphia and a development group in Atlanta.
Our Philadelphia lab focuses on hair follicle molecular biology and cell biology. Philadelphia is a logical choice because with University of Pennsylvania, Jefferson and other institutions, there is already a strong hair biology culture in the region. Dr. Kurt Stenn is in charge of the Philadelphia group and the Chief Scientific Officer of ARI.
The seed of the Atlanta group was BioAmide and they have an engineering focus. Just as there is such a strong biology culture in Philadelphia, we feel the tissue engineering culture and environment is so strong at Georgia Tech and Emory that it is an affiliation we do not wish to lose. The Atlanta group is made up of the chief scientist from BioAmide, Tom Barrows, and we have a group down there working on things I call "development", which essentially means taking the science and translating it into the actual substance you are going to implant into the skin, like the actual structure of the hair seeds or hair progenitor cells.
#5 Hairsite: Can you tell us more about this technique that ARI is currently researching? Does it create a brand new follicle or does it rejuvenate existing dormant or inactive follicles?
Dr. Washenik: Our plan is to create new follicles. We don't expect to rejuvenate dormant hair follicles, but if that happens, we would be thrilled and that would certainly be a very pleasant surprise.
This may sound like a marketing slogan, but Dr. Lee Bosley often says "hair transplantation is minor surgery but major artistry" because the doctor is deciding where to place the grafts in order to achieve the desired artistic effects. With tissue engineered hair growth or follicle neogenesis, we are creating a brand new follicle and the onus is on the person implanting the hair seeds to create an artistically acceptable result. On the contrary, if old follicles can be rejuvenated, that would be wonderful because we do not have to worry about the hair direction and angle. Everything is already predetermined by nature and we simply have to restart the process. Right now our focus is creation of new follicles, but I would be thrilled if we can rejuvenate dormant hair follicles too.
#6 HairSite: Since we are creating new follicles with this technique, does it mean that theoretically we can have more density than we were ever born?
Dr. Washenik: Yes.
#7 HairSite: Can you tell us more about the focus of this new technique? Is it just a basic form of cell therapy procedure or is it a more sophisticated technique that relies primarily on tissue engineering?
Dr. Washenik: We have one goal, i.e. the creation of new hair follicles. But to get there, we are not pursuing just one line of research. I find that research sometimes pulls you rather than you pushing the research. Very often you just follow the opportunities presented to you as you go along and you have to be prompt to react to any leads that are promising. Our one singular focus is to take cells from hair follicles, culture them, allow them to multiply and then repackage them in such a way that they can induce or create a new follicle when placed back into the scalp.
We are not working on two separate protocols. We use a combination of cell therapy and tissue engineering. Cell therapy research in Philadelphia, and tissue engineering research in Atlanta.
#8 HairSite: How would you compare Aderans' research with other organizations or scientists who are also experimenting with a similar procedure for hair loss?
Dr. Washenik: Right now most researchers seem to pursue one basic concept. The focus is to take cells from hair follicles, culture them, allow them to multiply and then repackage them in such a way that they can induce or create a new follicle when placed back into the scalp. There are only two groups of cells to work with, follicular fibroblasts and follicular keratinocytes. Based on the scientific literature, researcher seems to suggest that the follicular fibroblast is the driving force in the formation of hair follicles. The different groups are bound to have some secrets or proprietary knowledge that are not shared with the public. It would be impossible for me to do a meaningful comparison just based on superficial observations.
What may be infuriating to you is that the thing that sets us apart from other researchers is the actual thing that I cannot discuss. The basic concept is public knowledge to everyone, but we are all doing something different.
#9 HairSite: Do you anticipate a nasty courtroom battle over the patent issues?
Dr. Washenik: People often say a patent is only an invitation to the courtroom. There will be arguments no matter who comes out with hair multiplication first. But I think it will eventually take care of itself. Right now I am not aware of anyone slowing down his research because of the anticipation of a courtroom battle. Also, the court may view the existing patents as so similar and so general that they will not be useful. If existing patents worked, we would have had hair multiplication available many years ago already. There are bound to be some secrets that maintain the inductive potential of the cells. I don't envision the possibility of a nasty courtroom battle among the different groups. I envision there will be different versions of HM. There might be arguments, but I don't think it will keep the technology from coming out to patients.
#10 Hairsite: What is the reason for FDA review requirement? Is that because the procedure involves putting a foreign substance or material into the body? It is our understanding that procedures involving simple autologous transplants of unmodified cultured cells do NOT require FDA review. Can you comment on that please?
Dr. Washenik: Yes. FDA approval is required. It is true that you do not need FDA approval for autologous procedures such as a hair transplant or skin grafting. But the difference here is when you take cells form the body and work with it in the lab, whether you call it modifying or manipulating, you are doing something with the cells and this requires FDA intervention.
#11 HairSite: Are you aware that the FDA has an expedited review process for new medical procedures that are promising and can potentially help many people? Under such an "expedited" approval process, clinical trials might be shorter in duration, and the actual application for approval might begin not after the trials were concluded, but DURING the trial period so that the FDA is monitoring the trials while they are being done. Do you think if Aderans' research can benefit from this expedited review process?
Dr. Washenik: Yes, I am aware of the expedited review process. However, I do not expect to have an expedited review for hair growth. The reason is that despite how much hair loss can bother you, it is not a life-threatening problem, it is a life-affecting problem. Granted, it's on our mind every day, but unfortunately that is not enough for expedited review by the FDA.
#12 HairSite: Does ARI, BioAmide or Bosley Medical currently have any applications for review or approval of any procedure pending with the FDA? Have you or anyone from ARI, BioAmide or Bosley Medical discussed any of your proposed procedures with FDA? Has any paperwork been submitted or filed with the FDA in connection with an application for clinical trials, review, or approval of any cell therapy, tissue engineering, or biotechnology-related hair restoration procedure, including the one described in the August 8, 2002 patent?
Dr. Washenik: If it is okay, I would rather not address this issue today.
#13 Hairsite: t has come to our attention that BioAmide has a new patent dated August 8, 2002 titled "Hair Follicle Neogenesis By Injection Of Follicle Progenitor Cells". Is this patent the core foundation of the eventual treatment or cure that will be available to the public or is it just one of the many techniques that ARI is experimenting with?
Dr. Washenik: We have several patents. I would be surprised if the actual end process is directly from any of the existing patents. These patents are ideas our researchers consider as promising, they are not necessarily the core foundation or protocol for the eventual procedure. What I can tell you is that it is unlikely anyone can just take cells from the head, let them grow in the lab and place them back into the skin and have hair. If it was that simple, we would have had this procedure available in the early 90s. People have been putting cells into skin and not consistently growing hair, so there may be more to it than what you learn from the patents. Very often, these patents are just possible ways to optimize the concept of putting cells into the skin.
#14 HairSite: Would you say that the procedure according to BioAmide's August 2002 patent appears to be somewhat invasive with a fairly large margin of error especially when performed on a large scale on a patient?
Dr. Washenik: The concept in this patent is very preliminary. This may or may not be the ultimate foundation of our procedure.
#15 HairSite: Can we anticipate more patents from ARI / BioAmide in the next 12 - 24 months?
Dr. Washenik: Right now we are researching something that is so exciting that it may not even be to our advantage to patent the knowledge at this point. As soon as you patent intellectual property, it becomes public knowledge. While patents can in most cases protect our proprietary knowledge, it may not always work in our best interest if we share our knowledge and ideas with the world at large too soon.
#16 HairSite: According to BioAmide's August 2002 patent, the protocol calls for certain wires to administer the delivery of the cell clusters into the patient's skin. Is it true that the reason for the wire is to control the direction of hair growth?
Dr. Washenik: Yes. One of the challenges with follicle neogenesis is the orientation of hair direction. If you look at the mouse models, some over produced the tissue engineered hair and they grow at all different angles, so we think there might be a need to guide or force the hair to grow in the correct direction or angle. Hair direction is an active area of investigation by ARI.
#17 HairSite: What are some of the obstacles or stumbling blocks that need to be resolved?
Dr. Washenik: The very basic and yet most critical is the issue of safety, for example, will the procedure induce the growth of something other than hair in patients? Also, among some of the other issues that need to be resolved are hair quality, hair direction, and hair cycle. Equally important is whether the new procedure will induce follicular groupings or not. If they are just generating single hairs, we might have to do this technique in conjunction with conventional follicle based hair transplantation to achieve cosmetically acceptable results.
#18 HairSite: According to some studies, one problem cited with hair follicle or dermal papilla culturing is that the cells may lose their phenotype with multiple passages, thus limiting how many cells you can culture from one and still get follicular differentiation. Is this true? Has this issued been solved?
Dr. Washenik: Yes. This is still very much a challenge for researchers nowadays and is currently one of the areas of investigation by ARI.
#19 Hairsite: This question gets asked a lot in HairSite. When the new procedure become available to the public, will Bosley Medical give someone a hairline that in your opinion may not be appropriate for his age?
Dr. Washenik: We do and will continue to do things that we believe in and are proud of. We would not purposefully do something that would make someone look unnatural. I would say no to a request for a hairline that would make the patient look unnatural.
#20 HairSite: This may be premature, but when this new technique becomes available, how much do you think the cost will be to restore a Norwood 6 to a Norwood 1? Do you think it will be as expensive as hair transplantation these days?
Dr. Washenik: It is premature. This is too early for me to give you any meaningful prediction. We don't have a workable protocol yet. But based on my experience in the research and medical community, it is always expensive when a new procedure first becomes available. I don't believe it will be a low price alternative to hair transplantation. I predict it will be at least as expensive or more than likely more expensive than hair transplantation, but I am happy to be wrong.
#21 HairSite: Do you think the eventual results will be heavily dependent on the skills and techniques of the surgeon much like the case with traditional hair transplantation nowadays?
Dr. Washenik: I believe it will be user dependent just like conventional hair transplantation, minor surgery but major artistry. In the end, we will probably have follicle based transplants and cell based transplants and both would still rely on the skills and techniques of the doctor. Our goal is to create new follicles and the artistry element remains very important.
However, if these progenitor cells can rejuvenate dormant hair follicles, then it would be much less demanding and the skills of the doctor would not be as important.
#25 Hairsite: When do you expect this new procedure will be available to the general public? Can you give us an estimate?
Dr. Washenik: I said about 10 months ago that realistically it would be five years. So if you hold me to that prediction, it would be four years now. Having spent a year really immersed in this work, I would say without any sense of disappointment five years again. You would look at this and say it sounds like I am back pedaling because now I am backing up a year, but I still think five years from now is very reasonable.
The 5-year prediction is inclusive of the FDA approval process. I believe that the regulatory pathway may take approximately 3 years once you have the actual protocol ready for the market.
There are so many unpredictable twists and turns. While I cannot guarantee anything, I feel that at a minimum, this technology will be at least in the later stages of clinical trials 5 years from now and if that is the case, I would not consider myself disappointed.
5 years may sound optimistic, but it could feel like a lifetime for people losing their hair. That's unacceptably far away for some people losing his hair. If you asked me about a prediction for cancer cure, I would never say five years. But for the case of tissue engineered hair growth, I think there are plenty of promising data and experimentation out there. That's why I am optimistic.
#26 HairSite: Do you anticipate any major obstacles? What are the chances that this research will be suspended or delayed?
Dr. Washenik: No major expected obstacles, otherwise I would not give that prediction. But of course you can always get surprised.
The bottom line is that we are excited about what we are doing. We put together a core group of highly respected researchers who view this as legacy work. This is a full time focus. Bosley is the driving force behind the creation of this research group and we have a parent company with a lot of foresight and forward thinking that put this together. I joined Bosley because I am confident in the surgical work they do. I am also firmly assured of Bosley's commitment to this project. I also view this as legacy work. In the scientific community and medical community these days, one of the biggest areas is tissue engineering and organ neogenesis. This could be our chance with hair.
Also, I don't believe there has ever been such a large focused, singular industrial effort doing this until we established ARI. We will not accept disappointment at the end of the line. Aderans is absolutely committed to accomplishing this. Aderans feels this is the future of hair restoration.
#27 HairSite: When the new technique is closer to release will Bosley Medical advise potential clients to hold off traditional hair transplantation procedures until this new technique can be done?
Dr. Washenik: I believe that when first generation hair multiplication becomes available, this is not going to replace conventional hair transplant. This will be an adjunct or complementary procedure to increase the density around conventional hair transplant. That's really my belief based on what I know at the moment. If I know hair multiplication will be six months away, I will still consider getting a follicle based hair transplant, and then use hair multiplication to increase my density.
#22 HairSite: How long does it take to culture the hair cells? Is it difficult to extract the cells? Also, how large a skin biopsy is required for the extraction process?
Dr. Washenik: It takes about 3-4 weeks to culture the cells. It is not difficult to extract the cells. The extraction process can be done in conjunction with a conventional hair transplant. You just keep part of the donor strip and send it to the lab at the time of your hair transplant surgery.
I suspect the punch biopsy will probably be the size of a pencil eraser, about 4-6 mm in diameter. I can't accurately answer how many hairs that will translate to, but it should be enough for a lot of hair.
#23 HairSite: Besides male pattern baldness, what other conditions involving hair loss can this new technique treat?
Dr. Washenik: Besides, male pattern baldness, this procedure can theoretically treat scar tissue, traumatic hair loss as well as female pattern baldness. We are unsure about alopecia areata because it is possible that the person's immune system will still attack the cells and/or new follicles.
In addition, some patients without obvious alopecia may just feel that they would like more hair, thicker hair and cell based therapy will be able to satisfy their needs as well.
#24 HairSite: So far our discussion is mainly focused on creating new hair follicle using autologous cells. What are your opinions of allogeneic based hair multiplication procedures, i.e. deriving the donor cells from an individual other than the patient himself?
Dr. Washenik: The first and second generation of hair multiplication will most definitely be autologous procedures. Most people I've spoken with now believe autologous procedures will come before allogeneic procedures. Some people made convincing arguments for allogeneic procedures a while ago, but they have since come around and changed their views on this issue. Right now everyone seems to be looking at autologous procedures. We would be surprised if we came out with the allogeneic version of hair multiplication first.
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