There is still plenty of reason to worry about unproven stem cells being marketed in the U.S. and elsewhere around the world. I’ll start with a new item here in the U.S. on a firm called MD Stem Cells and end with a newly published paper about how things are going in Poland on this front.
MD Stem Cells
The firm in question is MD Stem Cells. I’ve written numerous times about my concerns about it. In many instances, patients argued these unproven offerings have harmed them too. From MedPage Today:
“Andrew Yaffa, a medical malpractice lawyer in Coral Gables, Florida, told MedPage Today that as many as 25 of Weiss’ patients have approached him “wanting me to sue him for various promises and representations and procedures that have not come to pass.”
MD Stem Cells is also offering experimental neurological stem cell interventions as well for a price.
Dr. Thomas Albini, who has seen several patients with vision loss due to stem cell injections including by another firm called US Stem Cell, had harsh words in the MedPage Today piece:
“They’re not neurologists,” Thomas Albini, MD, an ophthalmologist at the University of Miami’s medical school, who has conducted research on eye injuries from unproven stem cell treatments, told MedPage Today. “There’s so many things wrong with it. It is what it looks like — it’s total charlatanism.”
Those are strong words.
I don’t understand how the FDA seemingly continues to do nothing about the apparent non-homologous use of bone marrow cells. Or is it somehow homologous? Instead is it possible that the firm has one or more cleared INDs with the FDA?
Embryo models from stem cells: the story continues
I wrote last week about news out of ISSCR on human embryo models that get to around the 2-week mark of development. There have been several more developments on this front.
First, ISSCR issued a statement about embryo models, amongst other things arguing against using the phrase “synthetic embryos” for the models. I guess the idea is that these are not actual embryos, synthetic or otherwise. However, as I’ve written before, how would we know when a model is functionally equal to the real thing? The most important part of the ISSCR statement is the need for compelling reasons to do this kind of research and for careful approvals.
Earlier Jacob Hanna was reportedly very upset by how Zernicka-Goetz’s work was presented and how it was portrayed in the media.
Now that I’m back from traveling and mostly recovered from COVID (yes, it finally got me after three-plus years), I’ve had a chance to dig into this more. Some other embryo model scientists agree with Hanna on this and he may have a point in some ways.
The human embryo models in his newest preprint are impressive. His team’s methods also do not involve genetic changes to the cells/models.
Keep in mind again though that this kind of work has been ongoing for six years. This line of research by several labs will continue to get closer to the real thing. People are likely to continue to disagree on which models are “best” as well as relative strengths and weaknesses.
An important general point is that the human embryo models raise a host of ethical and societal questions that aren’t resolved.
Finally, Zernicka-Goetz was just awarded the Ogawa-Yamanaka Prize for her embryo model work.
More reads including 2 cell therapies in the pipeline
- Corrected: Bayer’s BlueRock group moves Parkinson’s cell therapy to PhII after clearing early study, EndPoints.The cell therapy drug here is bemdaneprocel (BRT-DA01), which is derived from human ES cells.
- In a first, FDA signs off on CellTrans’ type 1 diabetes cell therapy days after industry’s eyes fixated on Vertex data, EndPoints.
- Unproven cell interventions in Poland and the exploitation of European Union law on advanced therapy medicinal products, Stem Cell Reports. There are too many unproven cell therapies being marketed in Poland.