#bioheart

Kristin Comella resigns from embattled clinic firm US Stem Cell

US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1.

I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways.

To me Comella seemed like the driving force behind the company, which is now subject to an injunction after a big federal court loss. It is appealing the ruling, but faces a tough road ahead in…

In historic step, FDA & DOJ seek injunctions on 2 key unproven stem cell clinic firms

The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point for dealing with the for-profit stem cell clinic problem in the U.S.

Kris…

Stem cell fake news driving biotech investors or vice versa…or what?

Is there a proliferating stem cell fake news problem in the biotech world?

More broadly, the SEC is cracking down on the mess that is fake biotech news, but what about fake news on stem cell biotechs more specifically? Already in the past year I’ve seen examples of possible stem cell fake news.

Hyped press releases (PR) that might arguably be in part fake news are nothing new and there has always…

Does stem cell clinic IRB approval mean much? Insights from blinding cases

Could the blinding of three women at a stem cell clinic have been prevented by better oversight or was the clinic acting outside of the scope of oversight by its institutional review board (IRB)?

More broadly, when is an IRB conducting proper oversight and how do we know? When on the other hand is it not being careful enough or even outright enabling risky behavior by those selling…

NEJM paper links 3 blinded patients to publicly-traded stem cell clinic

Do 3 blinded stem cell clinic patients with major or complete vision loss constitute a significant adverse outcome?

I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business.

You can see the damaged retinas of one such patient below in an image from a new NEJM paperreporting the severe adverse outcomes. The red…

Grading my top 20 stem cell predictions for 2016: how’d I do?

Below are the 2016 stem cell predictions I made last year and their status now color-coded near year’s end. Green is right, orange is mixed bag, and red is flat out wrong.

Overall, I did better than most past years with only having entirely blown it on four.

Stay tuned later this week for my 2017 predictions, which looks to be a dramatic year in the field of stem cells and regenerative medicine.