Due to technical issues with HM consistency, ARI’s technique has a far greater chance of success than Gho’s or ICX’. Gho was the early pioneer and actually used CD34+ stem cells from the patient’s blood to fortify the nutrient mix and enhance the hair follicle stem cells ability to multiply and remain viable. But despite his brilliant pioneering idea, he could never develop a consistent protocol.
Gho had done some early research into ICX’ technique and abandoned it in favor of using hair follicle stem cells mixed with blood stem cell aggregates and kerotinocyte growth factors. Thus, unless ICX could figure out some new way to culture viable DP cells in 2-D suspensions, their research was bound to come up against (and did) similar consistency issues as Gho encountered.
ARI has spent a great deal of time in the lab studying these issues and outcomes, and they’re very familiar with the problems other researchers have encountered. Their emphasis is on 3-D environments using a multi-cell approach. IOW, they specialize in creating a self-contained environment that relies less on the patient’s existing cells interacting with the injected cells. What separates this from previous companies’ trials is this has never been tried before in humans. So it should prove to be quite exciting.
ARI’s approach is not a backyard approach. Kurt Stenn is a world-class hair follicle researcher and has assembled a team of researchers with impeccable credentials. ARI has taken its time in the lab (mostly because the issues are so difficult to solve), but I see this a good thing. The earlier attempts by other companies have been thwarted more than anything by lack of developing a consistent protocol prior to moving into human research. ARI’s approach is different on many different levels and stands a high chance of commercial success. The amount of time and experiments they performed in the lab leading up to human trials is unprecedented. In many ways, this is the real deal this time. However, despite this, I expect the product will be clunky when it’s first released (if it makes it that far).
Phase II trials are typically 20-300 people, so ARI’s effort can be thought of as a legitimate mid-level attempt (quite expensive). If they have success, most likely the phase III trials will be quite a bit bigger than phase II. Phase III trials typically involve 300-3000 people and cost an arm and a leg. So if we see a failure, it will most likely play out in phase II with a reluctance to continue funding.
Technically ARI could finishes phase II in a year, enter and finish phase III in another year, and then submit the product for FDA review and get it on the shelf. However, that is not likely to happen. 2.5 years is possible, but “5 years” is more likely. LOL