In the News – Are Your Stem Cells a Drug to be Regulated by the FDA?

Snippet from the article:

There’s trouble brewing over stem cells in Texas, and it raises a big question for the future of medicine. How should we regulate treatments that use cells taken from a patient’s own body?

If the cells are grown in culture, then the US Food and Drug Administration (FDA) views them as “drugs”, which must undergo a lengthy approval process. That has enraged clients of a company in Houston called Celltex, who argue that the government has no business telling them what they can and can’t do with their own body parts.

Read the rest — Whose stem cells are they anyway?

It seems like nearly every day I am asked, “When will we have stem cells to grow our hair?” The author of the above editorial published in New Scientist earlier this month wonders about regulating our own cells. Unfortunately, the FDA says that if cells are grown in cultures, they will be treated as drugs which must undergo a lengthy approval process, possibly costing us far more in time and money than we can afford. This impacts cancer treatments as much as the search for the “hair holly grail” from which we can extract stem cells.

There are arguments raised that simple transplants are the practice of medicine and therefore not under FDA control. There seems to be some direction to this controversy. “Strict drug-style regulations” seem appropriate for extensively manipulated cells. What that means is still unclear, but the questions are the start of agreements on differentiating the practice of medicine from FDA safeguards for drugs.

So this is what I tell my patients — Any solution for hair regeneration will most likely go through some regulatory process which will slow down the availability of any “cure” coming out of stem cell research. Don’t hold your breath!