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Hair Cloning - Dr. Ken Washenik - Video Story 9th Oct


#1

BREAKING HEALTH & MEDICAL NEWS - Video Stories

Hair Cloning
Bald is beautiful these days. But not everyone wants to be hairless.

The condition of hair loss does affect half of all men by the age of 50 and in fact half of all women who are in their menopausal years.

But relatively soon it appears, baldness will be an option, only if you choose it–because you’ll be able to clone your hair-producing cells.

“A woman’s hair is her crown and glory, it represents beauty and youth and you know to be young and losing it, it is devastating as devastating as having your breast removed and needed reconstructive surgery.” These are strong words from 33 year old Jeanine Acca, who started going bald 11 years ago. But they demonstrate how emotionally charged the problem of hair loss can be.

It got so bad, Jeanine decided to have a hair transplantation, which involves transplanting–moving–the entire hair follicle from dense areas of hair growth to the balding areas.

But in the near future, this procedure may be old hat.

The problem with follicular transplants is the finite supply of donor hair. Eventually, it runs out.

What if there was a way to grow new hair–that would match the person’s color, texture, and growth pattern? It can now be done through a process called follicle neogenesis—hair cloning. It takes advantage of the fact that hair follicle cells like to multiply… a lot.

As part of a routine transplantation, doctors would remove around 100 hair follicles. The cells of these follicles are nurtured and encouraged to grow and multiply.

About six to eight weeks later, the patient receives many more of his or her own follicular cells than were removed.

And those cells create numerous new hairs.

“The thing that hair cloning means is that for the first time the ability to get past the limitations of the amount of donor hair you have.//This will be the first time you can actually make more, if you need more,” says Dr. Ken Washenik, Medical Director of Bosley Hair Instititute.

This technology will be used to augment or add to the density you can get from a conventional follicle based transplant.

“We can get a hair follicle to form in as little as eight days, but// in the human it will probably be similar to when you move an intact follicle and it will take around twelve weeks or three months for that follicle to organize and grow up through the skin so about the same time,” says Dr. Washenik.

Jeanine is happy with her follicle transplant, but she’s not done yet. “If hair cloning was available today, I would be the guinea pig on the table, without a doubt, I would defiantly do it. Who knows maybe one day I will have more hair than the average person,” she hopes.

So far, there has been one phase one study, the initial phase of study, completed by a group of researchers in England on hair cloning.

Dr. Washenik says they will be submitting an application to the FDA in the next few weeks to start clinical trials here in the u.s.

The hope is that it will be available in just a few years.

See link
http://empowereddoctor.com/story_878.html


#2

Then count on it coming out after 2010. Funny, in the other video he said late 2009/early 2010. I thought Phase I already started…


#3

» I thought Phase I already started…

That is in England. The FDA submittal is here in the US. Interestingly, Aderans stated years ago that they were in talks with the FDA and nearly ready to submit for Phase I. Obviously, something held up that process.

That’s the typical story when it comes to developing bleeding edge medical inventions. People should take note of that when they claim ICX will debut HM in 2008. On more than one occassion, Paul Kemp has stated “2010 at the earliest.” Keep in mind that he might be being optimistic here just as Washenik was when he stated “5 more years” 5 years ago. And look, ARI still hasn’t officially made it to phase I of FDA trials. Thus, by Washenik’s own admission, the soonest ARI can release HM is 3 more years if everything goes smoothly from this point forward. Unfortunately, the old familiar story with HM is that nothing ever goes smoothly or according to plan. :slight_smile:


#4

Despite the current timeline required to push HM to the masses, things look quite good on the HM front. I just hope people are are not camped on the edge of their seats expecting to get this technology next year. Cause if that’s the case, I expect that these people are going to be in for a very big letdown :slight_smile:


#5

I just wish they’d find out the way and get it out, I’m getting a bit impatient.


#6

» Despite the current timeline required to push HM to the masses, things look
» quite good on the HM front. I just hope people are are not camped on the
» edge of their seats expecting to get this technology next year. Cause if
» that’s the case, I expect that these people are going to be in for a very
» big letdown :slight_smile:

I’m going to go out on a limb and say limited commercial availability (probably only in 1 or 2 locations in the UK only), for ICX-TRC (not Aderans) in late 2008. It is possible that this will happen while data is still being gathered from Phase III trials.

This is just a prediction, people – I am not infallible and I’m not implying it’s a God-given fact. But I am entitled to make predictions! :wink:


#7

» » Despite the current timeline required to push HM to the masses, things
» look
» » quite good on the HM front. I just hope people are are not camped on
» the
» » edge of their seats expecting to get this technology next year. Cause
» if
» » that’s the case, I expect that these people are going to be in for a
» very
» » big letdown :slight_smile:
»
» I’m going to go out on a limb and say limited commercial availability
» (probably only in 1 or 2 locations in the UK only), for ICX-TRC (not
» Aderans) in late 2008. It is possible that this will happen while
» data is still being gathered from Phase III trials.
»
» This is just a prediction, people – I am not infallible and I’m
» not implying it’s a God-given fact. But I am entitled to make
» predictions! :wink:

What do you base your prediction on? Why would the MDA (or whatever they are called) change their opinion of not treating TRC the same way as RHY? There is no indication that they will.


#8

Because although you’re absolutely correct that the MHRA decided not to treat TRC the same way as RHY, I think you have your timetables mixed up a little bit for the two procedures.

Intercytex sent out this press release about RHY in July 2006:

http://www.intercytex.com/icx/news/releases/2006/2006-07-20/

Note that at that time, they were already announcing that RHY would become available on the market in the UK in the second half of 2007. That was BEFORE they had even applied for approval of Phase II clinical trials. (Read the press release and you’ll see that).

With TRC, they are already in the midst of Phase II trials, and these Phase II trials will most probably be finished sometime in 2008, I am guessing the first half or early in the 2nd half.

So notice how the progress of TRC currently is well ahead of where RHY was when they issued that press release.

I think that with completed Phase II clinical trials, they will be in a position to seek a approval of limited commercial availability for TRC in 2008.

It is not even unusual in the US for the FDA to grant approval for commercial availability at the conclusion of Phase II trials, but before the conclusion of Phase III trials. The limited commercial availability occurs while Phase III trials are being done, and observations of the results from those commercial patients goes into the Phase III data.

It’s just sort of equivalent to ICX asking the MHRA, “can we collect a fee or a payment from some of our Phase III patients?” They are not technically considered official Phase III patients, but both MHRA and the biotech or pharma companies desire to collect as much data as possible, and this allows them to expand the numbers of patients from whom Phase III data can be collected.

This scenario, or something very similar, has happened quite a bit in the US.


#9

» Because although you’re absolutely correct that the MHRA decided not to
» treat TRC the same way as RHY, I think you have your timetables mixed up a
» little bit for the two procedures.
»
» Intercytex sent out this press release about RHY in July 2006:
»
» http://www.intercytex.com/icx/news/releases/2006/2006-07-20/
»
» Note that at that time, they were already announcing that RHY would become
» available on the market in the UK in the second half of 2007. That was
» BEFORE they had even applied for approval of Phase II clinical
» trials. (Read the press release and you’ll see that).
»
» With TRC, they are already in the midst of Phase II trials, and these
» Phase II trials will most probably be finished sometime in 2008, I am
» guessing the first half or early in the 2nd half.
»
» So notice how the progress of TRC currently is well ahead of where RHY
» was when they issued that press release.

»
» I think that with completed Phase II clinical trials, they will be in a
» position to seek a approval of limited commercial availability for TRC in
» 2008.
»
» It is not even unusual in the US for the FDA to grant approval for
» commercial availability at the conclusion of Phase II trials, but before
» the conclusion of Phase III trials. The limited commercial availability
» occurs while Phase III trials are being done, and observations of the
» results from those commercial patients goes into the Phase III data.
»
» It’s just sort of equivalent to ICX asking the MHRA, “can we collect a fee
» or a payment from some of our Phase III patients?” They are not
» technically considered official Phase III patients, but both MHRA and the
» biotech or pharma companies desire to collect as much data as possible,
» and this allows them to expand the numbers of patients from whom Phase III
» data can be collected.
»
» This scenario, or something very similar, has happened quite a bit in the
» US.

But these are two very different procedures/products, one is autologous ánd the other is allogeneic for once. How can you come to any conclusion by comparing them? Because they both are aesthetic medicines?


#10

» But these are two very different procedures/products, one is autologous
» ánd the other is allogeneic for once. How can you come to any conclusion
» by comparing them? Because they both are aesthetic medicines?

Right, but the whole point was that the MHRA is treating them differently, probably for just the very reason you mentioned.

First, the two procedures were designed.

Then, MHRA considered the two procedures, separately, and came up with two different ways of dealing with them.

With RHY, it appears they got it approved for limited commercialization before Phase II was to be completed.

They adopted a different, more stringent, way of treating TRC, requiring Phase II to be complete before limited commercialization could be planned.

See how they’re treating the two differently?

The requirements for Phase I and Phase II and Phase III don’t change, but the timing of when limited commercialization is permissible can change, depending on how the MHRA decides to treat each procedure.

That is precisely how they’re treating the procedures differently.