Would Using Stem Cells for Hair Growth Need FDA Approval?

Hi,

Have you seen this article on Stem Cells for hair growth? Wouldn’t the FDA of had to approve this kind of treatment?

Link: Doctor has high hopes for new hair-loss treatment

Doctors have been doing this for a number of years. In fact, we tried the use of ACell with plucked hairs that were supposed to supply stem cells to grow new hair. We did this according to a protocol, had it approved by an institutional review board (IRB) and then took human volunteers to see if it worked. There was no growth with this technique despite it being promoted by other doctors who claimed success. Although we did not add platelet rich plasma (PRP) to the mix, the stem cells could be seen on the plucked hair. No response.

Using ACell and PRP is not something that the FDA must rule on. This falls within the confines of the practice of medicine. If something other than ACell was sold for this purpose and claims were made that could not be proven, then doctors who made unproven claims can be prosecuted by various state and federal agencies. The FDA uses terms like “safe and effective” and this has become impeded in the law of the land.

I would love to see this work, so I will keep a keen eye on those who are doing this and wait to see results. Seeing is believing, and so far, no evidence has been presented that this approach really works.