Each year I make a list of predictions for the stem cell and regenerative medicine field for the coming new year. Later in this post I list my top 20 stem cell predictions for 2017. In looking at my past predictions I realized this will now be my 7th year doing stem cell/regenerative medicine yearly predictions.
You can see below links to these predictions for past years, which sometimes seems rather far removed from today and in other cases strike me as strangely apropos of our times.
There has been relatively limited response from clinics themselves to the Cell Stem Cell paper that Leigh Turner and I published recently on the scope of the stem cell clinic industry in the U.S.
We found 570 stem cell clinics and there could easily be 50-100 more that escaped our search methods or that have popped up since we finished our search at the end of February. While not all the clinics necessarily require FDA approval depending on the type of stem cells and the uses, it seems almost certain that many should have gotten approval from the FDA for what they are doing before they started selling the unproven “treatments”.
One thing I was curious about before our paper even came out was what kind of response, if any, it would get from the stem cell clinics. It’s been pretty quiet from that quarter.
A few clinics talked to reporters who covered the paper and basically used some version of the same mantra, “not me, them”. This reminds me of the Family Circus “not me” cartoons (part of one is shown above).
The journal Nature published an excellent editorialearlier this week on stem cell oversight and stem cell clinics.
The piece, entitled ” FDA should stand firm on stem-cell treatments. US regulators must regain the upper hand in the approval system” struck just the right balance. It correctly supported the FDA’s data-centered approach to stem cell oversight and indicated that this regulatory system is not too harsh. At the same time, the editorial also rightly asserted that the FDA cannot simply stick entirely to the status quo and needs to be more efficient.
The editorial also hit the nail on the head by discussing stem cell oversight, the REGROW Act, and stem cell clinics all within one interconnected arena. That’s the reality of the stem cell world today. Too many FDA critics and supporters of a weakened oversight system essentially pretend the stem cell clinics are not going to be affected by efforts that would limit FDA oversight of stem cells.
It was great to see that the Nature editorial cited the new paper by Leigh Turner and I on the astonishingly large number of stem cell clinics in the US. Given the scope of the stem cell clinic industry in the U.S. (at least 570 clinics) and the remarkable range of conditions marketed to be treated using a variety of stem cell types, there are at the very least serious questions about compliance at some clinics because of issues related to more than minimal manipulation and non-homologous use. See Figure 2 from our paper above.