Spencer Kobren Speaks With RepliCel Life Sciences' CEO and President David Hall

[tbtadmin]

RepliCel Life Sciences was founded to advance the breakthrough findings of Dr. Kevin McElwee and Dr. Rolf Hoffmann, established research scientists in the fields of immunology, hair biology, hair growth, and dermatology. In the early 2000s, at Phillips University in Marburg, Germany, Drs. McElwee and Hoffmann discovered that dermal sheath cup cells have the ability to initiate cellular growth of mature hair follicles in animals. RepliCel is now developing this discovery as a potential successful treatment for hair loss in humans.

Listen To The Exclusive Interview:

[PayDay]

Unbelievably informative interview! I’m am stoked!! Spencer I just can’t thank you enough for what you do for all of us. Your opinion is so important to all of us and your enthusiasm about Replicel gives it more credibility. Thank you and thank you Mr. Hall for sharing this information with all of us.

[HelpROGER]

Unbelievably informative interview! I’m am stoked!! Spencer I just can’t thank you enough for what you do for all of us. Your opinion is so important to all of us and your enthusiasm about Replicel gives it more credibility. Thank you and thank you Mr. Hall for sharing this information with all of us.

What can I say, I'm so excited about his. I concur with Payday, Spencer you changed the path of my life when I found this site and your show. I was about to make a tragic mistake and now I have so much to look forward to. I better start saving up for this I hope it really happens!

[amadeus]

Nice! One question, will it work in scar tissue?

[krewel]

I'm so sad. 2015 feels like lightyears away for me. I was expecting 2014 or maybe even 2013. On 2015 I'll be like 25 years old

[CVAZBAR]

So this would not be available sooner than 2015 in another country?

[The Alchemist]

So this would not be available sooner than 2015 in another country?

The CEO stated that it could potentially be available in other countries, however, he didn't know for sure.

It would be great if the company Regenexx, the ones suing the FDA for overregulating their autologous cell treatment, won their case and loosened the restrictions for Replicel. Could speed things along for release in western countries. Here is an article i found about them:



Clinic Claims FDA Has Repeatedly Overstepped Regulatory Authority
DENVER, Aug. 9 /PRNewswire/

-- Regenerative Sciences, Inc., a Colorado medical practice that specializes in the use of a person's own stem cells to help patients avoid more invasive orthopedic surgery, announced today that the US Food and Drug Administration (FDA) is seeking to enjoin the clinic physicians from practicing medicine using patients' own stem cells. The lawsuit will allow Regenerative Sciences to question the FDA's policy that adult stem cells can be classified as drugs when used as part of a medical practice.

"The FDA will finally answer our questions, in court, about their claims and jurisdiction as opposed to doing everything in their power to avoid the issue that we are not a drug manufacturer, but simply a medical practice," said Christopher Centeno, M.D., Regenerative Sciences' medical director.

The FDA claims that Regenerative Sciences is using an "adulterated" product because it fails to follow mass manufacture guidelines in its medical practice that is applied to drug factories producing millions of doses. Rather than mass producing drugs, Regenerative Sciences uses the patient's own stem cells to treat common orthopedic problems. Regenerative Sciences has had an unblemished safety record, recently publishing a large study showing that its procedure is dramatically safer than the traditional surgical procedures it has helped many patients avoid. Regenerative Science's lab has strictly adhered to the International Cellular Medicine Society's (ICMS) strict, professional guidelines and has been audited three times by independent third parties with no serious safety concerns.

"ICMS lab guidelines are the best fit for autologous cell processing and provide strong patient protection. If the FDA had any valid concerns about our medical practice not using drug factory guidelines, they knew about that in Spring of 2009 and did nothing. They did nothing because there were no safety issues. Their focus on this now is litigation posturing," stated Centeno.

Regenerative Sciences has been using its patients' stem cells to treat orthopedic conditions since 2005 and received an untitled letter from the FDA in 2008 claiming its medical procedure was creating a new biologic drug. The FDA inspected Regenerative Science's facility in 2009, and found, at that time, that it was not compliant with drug mass manufacture guidelines, but failed to take any action.

Regenerative Sciences has filed two lawsuits against the FDA in an effort to force the organization to respond to questions about their jurisdiction in the matter. The medical practice filed a suit in Denver District Court in 2008 based on the issue that the FDA regulations regarding creating a drug out of the patient's own stem cells exceeded the FDA's congressional authority and that the Food, Drug, and Cosmetic Act contains exemptions for physicians using innovative therapies that do not go through FDA approval as part of their medical practice. Last month, Regenerative Sciences was forced to file suit against the FDA again, this time seeking a Temporary Restraining Order (TRO) to prompt the FDA to take "final agency action" or leave its medical practice alone following an exhaustive inspection of Regenerative Science's facilities and taking no action.

"For two years we've been prodding the FDA to respond to our questions about how it has the ability to regulate a medical practice, so we're encouraged that, as a result of this recent suit, the courts will decide if it the FDA has regulatory authority over the adult stem cells that live in everyone's body," stated Centeno. "This is an important case for everyone that suffers from any type of illness, not just patients with orthopedic problems. It will decide, once and for all, if the government has the right to restrict a patient and their doctor from using a person's own stem cells to treat disease. Regenerative Sciences believes that stem cells are body parts and not the property of the government or big pharma."

Adult stem cells are those found throughout the patient's body. Recent medical research has indicated these important cells have as much clinical promise as the more controversial embryonic stem cells (cells taken from an embryo).

"What we're doing in our Colorado medical practice is no different, in principle, than a fertility clinic that uses the in-vitro fertilization technique. The only difference is that we're using stem cells and fertility clinics use fertilized eggs," stated John Schultz, M.D., one of the founders of the Centeno-Schultz Clinic.

The FDA's lawsuit is being closely monitored by the International Cellular Medicine Society (ICMS), a global nonprofit dedicated to patient safety and education in the medical use of adult stem cells that represents over 1,000 physicians, researchers and patients from over 35 countries on 6 continents. ICMS executive director, David Audley, stated "The Centeno-Schultz Clinic meets our strict criteria for the safe therapeutic use of adult autologous stem cells. There is more medical and scientific evidence supporting this type of medical therapy for orthopedic conditions, for example, than there is for many approved drugs that the FDA allows to be used in off-label or unconventional applications."

[Sogeking]

Thank you Spencer and sincere thanks to CEO of Replicel Mister David Hall.
The questions asked were the right questions, the answers are still unknown but we will answer them more in Q1 of 2012, when first results are analysed.

I see that mostly new users are kind of disappointed becuase of 2015, release date as the best case scenario. Guys thats only 3 and a half years. Up until recently most hair loss sufferers were promised cures which were 10 years away. Now that is more troublesome. That said I don't believe in 2015 release date.
If they prove safety and efficacy I would expect the release date to be in 2016. at best.

However for me more important dates are the dates when the results from Phase 1 and Phase 2 are publicized. Becuase the wait is not a problem when you are waiting for a proven cure. It is much more bearable because you have hope pushing you.

All that said I would like to ask Spencer if it is possible to do another interview in 12-18 months if phase 1 results are favorable. Some sort of regular updates .

I defintely have my fingers crossed this works.

[elvispresley]

guys can someone for all the NON ENGLISH people like me , write a little short resume of the interwiew?

is also good for the NON LISTENABLE people. thx very much.

[The Alchemist]

Great interview and brings a little more hope

[CVAZBAR]

Great point Alchemist. Hopefully this could be available sooner but we still need to know how well it works. If there's no setbacks, they should offer asap. We need to pray and get ****ing lucky everything goes well.

[DepressedByHairLoss]

God bless Spencer for conducting this interview and doing all that he does for us. Anyway, I know that we're going to initially have to go outside of the U.S. and Canada for this treatment, and I hope that it's being offered overseas first. The FDA is totally corrupt and heavily in the pockets of the large pharmaceutical companies and their powerful lobbyists. So they're obviously gonna be totally unnecessarily hounding Replicel over their treatment. The article that The Alchemist posted totally illustrates this. So I'm really hoping that Replicel's treatment/cure is offered overseas as soon as possible. And since they're conducting their clinical trials overseas, then I think they probably are going to offer this overseas first. I, like so many other people on here, are really desperate to get our full heads of hair and will not mind travelling anywhere in the world to do this.

[Have Hope3]

What a great interview! Replicel sounds like a promising solution to all of our problems. I was also hoping to hear it could possibly be available to the public by late 2013 or 2014 but I guess that is wishful thinking. I just pray that there are no setbacks to make this process longer. I wonder why it could be available overseas before 2015 but not in Canada?? Now I just have to figure out what else to use besides rogain and propecia to get me to the 2015 target.

[superhl]

FDA -cost lives

The FDA cost more lives than it saves. Burdens the ederly with high prescription drugs prices. Criples innovation. The FDA should ONLY be concerned with phase 1 trials concerning safety. There should not be a phase 2 or 3. Let the markets determine if works or not. The US is moving away from innovation and countries like India are move toward innovation. If a company only had to prove safety, we all could have this procedure performed by the end of 2011. Write your legislatures. Better, vote the out!!!!!!!!!!!!!!!!

[NeedHairASAP]

how come he couldn't answer kobren when he asked if they've replicated a hair or rejuvenated a hair at all yet?


it doesn't sound like they've really done much yet at all... I'd tone down the excitement


I do hope it works though