Lets hope to God Replicel has identified genetic markers from which they can select trichogenic cells and tested it on human tissue grafted onto SCID mice before heading into Phase 2.
I don’t know how extensively the FDA will let them modify their methods from Phase I. But lets hope the modification is substantial enough or we’ll get the same lukewarm results as Phase I.
I still don’t understand how any company can launch Phase 1 without testing their technology on human skin grafted onto SCID mice. I mean why wouldn’t a company do this OBVIOUS test if it had spent 8 or 9 years to come up with a method of regrowing hair? Why would they wait until Phase 1 before they find out if it grows hair on human skin. Either I’m missing something or someone has been very negligent at the company.
Erin Ellis, Postmedia News Files
NATIONAL POST ARTICLE PUBLISHED ON OCTOBER 30, 2013
The cure for baldness? It could be closer than you think — i.e. among the baldness-proof follicles that usually reside at the bottom back of the head, stem cell researchers claim.
The company hopes to have a clinical trial with 120 men in Germany in the coming months as it works its way through regulatory requirements that could lead to licensing in Europe, the U.S. and Japan. It has already completed an initial trial of 19 subjects that found no serious adverse reactions six months after injections.
But RepliCel’s plan isn’t to bring its cell cloning all the way to market, Hall says. Rather, it wants to prove the effectiveness of the technology in the hopes it will be purchased by another company.