A recent article in Nature News about a stem cell transplant company called Celltex got me thinking again about safety.
The safety of stem cell-based therapies is kind of an obsession of mine.
A question comes to mind.
Are people realistic about what stem cells can do for them and the risks involved?
The answer unfortunately is a resounding “no!” even when it comes to those people giving out the stem cell treatments.
Let’s take the case of Celltex.
In the Nature article, a doctor who is involved in giving stem cell-based treatments with Celltex is quoted that “The worst-case scenario is that it won’t work”.
Wow that is just so totally wrong that it is disturbing.
Is that what they are telling patients as part of the informed consent process?
Scary to think about.
In reality the worst case scenario, even for autologous transplant, is death. The second worse case scenario is severe, life changing injury.
Yes, these things can and do happen even for so-called auto transplants where you get your own stem cells back as a treatment.
To illustrate the very real risks involved let’s take a look at three recent, peer reviewed articles.
First we have the article indicating that fat tissue is a rich reservoir of cells able to promote cancer progression.
Second, we have the paper describing how a trial using autologous transplant of blood cells had serious adverse events and had to be terminated early.
Finally, we have the article on stem cell transplantation outside the U.S. for a child Multiple Sclerosis that resulted in catastrophic encephalomyelitis, which could have been fatal.
These are just three recent studies and there are more.
Nature has an editorial, “The darker side of stem cells” accompanying this newsy piece. In the Nature editorial they are very critical of Celltex and state regulatory officials. They point out the following:
There is an ethical paradox here. How can Celltex propose clinical trials for stem-cell treatments while at the same time it is, according to a doctor involved, paying physicians to use those treatments — or supplying cells to doctors who would no doubt use them — in the clinic? Shouldn’t clinical trials be done before a treatment is given to paying patients?
Another standout quote is “Texas officials should take the FDA’s regulatory power over stem cells more seriously”.
The take home message from me as a stem cell scientist is that safety has to come first and I personally am opposed to stem cell-based treatments that are not explicitly approved by the FDA.
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The cancer research article talks about CD34 positive cells. RNL or Celltex uses CD34 negative cells. Don’t mislead people.
Jim, you are missing the point. Any kind of stem cell transplant has risk including autologous.
That’s what you wanted to say. If you don’t know, just say don’t know.
Do you know why Osiris Tx clinical phase III ended up a failure? That was not because they were not able to prove safety. They just couldn’t prove the statistical efficacy.
Your prejudice is in a dangerous level.
Are you going for iPS? How can you make such a dedifferentiated cell? By chemical cocktail or Lentiviral vector? That’s the pure risk. Please look back how Geron had to abandon embryonic stem cell tx, which is much safer than one using iPS.
Here is an interesting new development in the story.
http://retractionwatch.wordpress.com/2012/03/01/slate-retracts-story-on-glenn-mcgee-and-celltex-as-mcgee-resigns-from-company/#more-6656
Thanks, Mary. The slate retraction is almost certainly due to threat of litigation. It is then quite interesting timing that McGee resigns today, huh?
Impeccable timing.