Doctor Says Hair Cloning Will Be Available in 2 Years!
One of the doctors in this article says that hair cloning will be on the market in 2-3 years. Thoughts?
I always find the prediction of when hair cloning will be available to be interesting. For the past 19 years since I entered this field, the predictions on cloning have always been 2-3 years out. I am hopeful as all of you, but any breakthrough will take years to work its way through the FDA.
Hair cloning will not be out in 2 years. As someone who consults for the biotechnology industry, including on some programs involving stem cell therapy (which hair cloning is a derivative of), the technology has not yet advanced to a stage where controlled trials can be run. Once this occurs, multiple lengthy trials must take place to evaluate both efficacy and safety. By the way, once a development program of a new (non life-threatening) therapy is finished, it takes about 6 months for a company to prepare the regulatory (FDA) submission, a 12-month period for the agency to evaluate the submission, and an additional time between approval and availability to the public. So, even if ALL the studies had been completed today (and you would hear about it in company press releases and presentations at scientific meetings), there would be a considerable wait periods. I don’t have a good guess as to when this technology will be available.
I don’t understand, if no trials can be run yet on hair cloning, what are Aderans and Histogen doing? Is it not precisely hair cloning they’re developing? Histogen has repeatedly said they will have a product on the market around 2013-2015.
There is a difference between early stage work on small numbers of people and larger scale trials that regulators request to support the approval of products. My post was referring to the later. It is entirely reasonable to anticipate a product line this 3-5 years from now if everything flows perfectly. Remember that when a biotechnology or pharmaceutical company says they “anticipate”, it is the sane thing as saying “we are hopeful that…..”. I hope so, too! Bottom line, any meaningful results from clinical trials from a public company will be available through a press release, so you will be able to follow. And if a company is at “first base” and hopes to cross home plate by Year X, this is not a guarantee. In fact, most clinical programs of drugs and new therapies- unfortunately- are not successful.
Allen
I keep on getting an error when I type the anti-spam word so forgive me if my other answers eventually go through and this is a repeat. Many companies do inital trials on small numbers of patients and my reply (above) was meant to refer mainly to the longer, controlled trials required by regulators. The technology per se allows these initial observations and the results will dicate whether regulators allow larger trials. 3-5 years is a realistic time frame if things go well; but, recognize that companies who give such projections are essentially saying that they ‘hope” to have completion of a program and positive results by then. I hope they do too. The nice thing is that one can follow (via press releases) any advance by these companies and it is typically not a mystery when a program is flowing successfully (Phase 1, Phase 2, Phase 3, submission, regulatory decision).
“As someone who consults for the biotechnology industry, including on some programs involving stem cell therapy (which hair cloning is a derivative of), the technology has not yet advanced to a stage where controlled trials can be run.”
Sorry Dr. Lyn, but your credibility as a knowledgeable source on this topic is undermined by this above statement. Aderans has indeed advanced to (and nearing completion of) Phase II – that is, a ‘stage where controlled trials can be run – of approximately 200 patients, which is actually a larger than usual sample size for Phase II. Get in the know, my friend.
Of course, we could be splitting hairs and say that you were referring to hair ‘cloning’ whereas Aderans is developing hair ‘multiplication’, but I believe one would be disingenuous in making that distinction.
Bill, what’s the expression? “No good deed goes unpunished?” You need to learn a little about drug development. Aderans has finished a very small uncontrolled Phase 1 safety study in the United Kingdom. Yes, they are now recruiting for a larger Phase 2 study that is controlled and will provide saqfety and efficacy data (as you note); if sucessful, this will be followed by more studies including long term safety data. So, bottom line, they have no data from any controlled studies and this was the point of my post to Allen and other readers thinking that something is “around the corner”. True, my note that the “technology is not available for controlled trials” was not stated well but was meant to imply that data is not yet available. And about your “200 patient” comment for me to get in the “know”, don’t be naiive. The FDA requires 1500 patients to be exposed to any “drug” or “procedure” for non life-thereatening illnesses. To pretend that 200 patients in a Phase 2 trial is massive (when its OK) suggests to me that you dont read medical journals.
Nobody disputes the minimum total participants required in an FDA trial, but you’re dodging the point: 200 participants is a lot for PHASE II.
I am not saying something is “around the corner”. But your excuse on why you said “technology has not yet advanced to a stage where controlled trials can be run” statement is a tad bizarre:
“True, my note that the “technology is not available for controlled trials†was not stated well but was meant to imply that data is not yet available.”
WHAT?! Sorry, I don’t see the connection there that would lead to this kind of misstatement. It’s okay to concede that you weren’t aware of Aderans’ progress prior to getting into this back-and-forth.
And for the record, they are not just starting to recruit for Phase II. Phase II started in April 2009 and they are now expanding based on the promising data they have collected so far – this according to their press releases. So clearly your statement that they have “no data from controlled trials” is wrong. With respect.
Lol @ Dr. Lyn’s naivete.
Doctors without any credibility usually bash hair multiplication to sound enlightened. Dr. Lyn clearly had no idea how far Aderans progressed in the past couple years.
I’m not saying the science will work (because we all know where that kind of blind optimism leads), but I do find it hysterical how Dr. Lyn pretends to be a champion of hair multiplication. Just bash the research while its in development, and then pretend to be an innovative, open-minded advocate when it finally comes to fruition. Sounds foolproof to me.
Btw, the whole “clearly you don’t read medical journals” is absolutely shocking. That is seriously one of the most pompous statements I have ever read.
I hope it made you feel really smart… because you sounded really dumb.
Regarding Bill and Rabbit’s comments I dont think the doctor is intending to be pompous at all I think he’s just trying to put it all into perspective.And not raise peoples hopes (like Intercytex! with there 3 to 5yrs prediction) Considering that really no product has been created initially for curing hair loss (Finastride and Minoxidil all are medications that where developed for i think blood pressure, and supposedly have side effects that stop or slow hair loss) I can never understand while people hate on these doctors that give there time to help inform us. If they agree or disagree with hair cloning available in 2yrs its not going to change the science!
I’m balding and pretty sad about it but I don’t buy into these rumors at all. 2 years away? I have heard that way way too many times. I’m not jaded but the real cure is years away. Dr. Lyn is telling us that we shouldn’t buy into these hypes. Bill and Rabbit, you guys must be really desperate. Totally understandable.
Please! Let’s stop all this in-fighting – we’re all here for the same pupose! Let’s all relax, link arms, and sing a song…how about “Hair”?
“She asks me why…I’m just a hairy guy
I’m hairy noon and night; Hair that’s a fright…”
I’m sorry, did you miss this part? “I’m not saying the science will work (because we all know where that kind of blind optimism leads)…”
Reading comprehension fail? Or just looking for a reason to suck up to Dr. Lyn?
True,
Provenge is for treating advanced prostate cancer patients, not cosmetic hair loss……. which suggests to me that you lack common sense.
Allen,
Where do you get off saying that everyone is “obsessing” over cloning nonsense? Seriously, who said that?
No one is going “OmgOmgOmg cloning iz like HEEERE you guyzzz!” – We are just providing a counterbalance to the uninformed bias that exists on this blog.
Hair multiplication is extremely complicated and, therefore, unlikely to work. A toddler could tell you that – you don’t need Dr. Rassman and Dr. Lyn.
I hope they don’t even bother with the FDA. America is a joke. Just open a clinic in Mexico. Then I can mix hair cloning and margaritas. All win.