What can go wrong with unapproved stem cell clinic offerings? The answer including from presentations at the FDA today turns out to be very serious, negative results right here in the U.S.
Thomas Albini, MD gave a talk entitled, “Severe Visual Loss After Intravitreal Injection of Autologous Adipose Tissue-derived Stem Cells for Age-related Macular Degeneration”.
Stem cell clinic transplants of fat stem cells led to blindness in three women, reported Dr. Albini.
We’ve heard encouraging news about how stem cells might help patients regain lost vision or preserve existing vision in the face of a disease like macular degeneration in the future. There’s real potential there with rigorous clinical trials that are ongoing.
Here in this very different case we heard from Dr. Albini about how stem cells inappropriately used by a stem cell clinic in South Florida reportedly caused 3 women to go blind. All had retinal detachment potentially, Dr. Albini said, due to the fat stem cells taking up residence and resulting in pulling of the eye tissue internally. A nurse practitioner reportedly did the transplants rather than a physician. The patients assumed, we were told in the talk, that the listing in clinicaltrials.gov of the “trial” meant the interventions were legit.
This is such a deeply tragic case we can only hope that more people aren’t blinded from this kind of stem cell clinic offering. More on this situation here at Nature by Heidi Ledford.
Michael Miller, MD, PhD, spoke next with his talk entitled, “Glioproliferative Lesion of the Spinal cord Arising from Exogenous Stem Cells.” This case already has had quite a lot of media attention and involves stroke patient Jim Gass, who ended up with a large spinal tumor that dramatically negatively affected his health. We have to give Mr. Gass huge credit for having the courage to go public with this case. He got ES cells and allo MSCs both in China. Then he traveled to Argentina for autologous MSCs and then to Mexico where he got MSCs and neural stem cells. See image above from the talk. The spinal tumor had many weird features of various primitive tumors. It was clearly a malignancy. There were no major cancer-related mutations detected in the OncoPanel assay.
The bottom line. So when those promoting stem cell clinics or wanting much less oversight ask “what can go wrong?” and they don’t really believe much can go wrong, we now know for sure that that view is just not accurate. Intensely bad stem cell clinic outcomes are occurring right here in the U.S.
Look – everyone knows Paul’s modus operandi in this blog – it’s become a little bit boring – but there is something much more serious happening here – the stem cell sector is in essence imploding – in the recent history of biopharma innovation, stem cells have had a very long run and have in essence gone nowhere – big pharma has lost interest, VCs rarely invest in the sector, public models have poorly gambled with tax payers $$ – all with very limited outcomes in terms of efficacy – Paul knows this, and like many idealistic researchers who have made a bet on a specific scientific discipline, and then come to realize their era is coming to an end, will turn to lashing out against any alternative model that is trying making a go at it – the paradox is it is the very flawed FDA model of insane over-regulation that he clings to that is indirectly killing off his research money
And news like this isn’t helping.
Stem cell company paid $443,500 to former head of state agency that funds research
http://www.sacbee.com/news/state/california/article99432362.html
Somehow, it’s blog worthy to post conjecture about stem cell patients “possibly” being given hundreds of dollars by “dubious” stem cell clinics to travel to an FDA meeting (still waiting for any evidence of that) but it isn’t “dubious” at all when Irv Weissman (this week’s FDA keynote speaker) is involved with giving the president of CIRM hundreds of thousands of dollars after CIRM awarded his company tens of millions of dollars under questionable circumstances. Really?
So do tell, what are we learning from the untested therapies given by clinics like yours and the people that die there?
http://www.abc.net.au/news/2014-09-16/stem-cell-methods-doctor-ralph-bright-untested-clinical-trials/5748588
https://www.ipscell.com/2016/06/womans-death-after-no-big-deal-fat-stem-cell-therapy-coroner-investigating/
We learn many things about how to use these cells. As an example we have learnt enough about migraine that we are currently enrolling in a double blinded placebo controlled trial treating migraine with adipose derived SVF cells.
Things can and do go wrong with any treatment. Panadol kills patients. So can many other treatments. Things will go wrong with stem cell treatments. Clinical trials seek to have every safeguard in place to reduce or prevent adverse events but still they will occur. Most important is that we learn from these events and build that knowledge into patient management as we move forward. The effectiveness of safety systems that have improved with time and that continue to improve was very clearly demonstrated in the landing of an Airbus on the Hudson River. Miracle on the Hudson. Safety systems in medicine are very extensive, have developed over time and continue to improve. As these adverse events occur we can be thankful that they are well publicised and that we all have the opportunity to set in place safeguards that improve our systems. There will always be patients, scientists and doctors who want to pioneer innovative treatments. This is the history of mankind. Let us celebrate the pioneers as we improve our safety systems.
Interesting debate happening about how reliable a reference source clinicaltrials.gov is when looking for “real” trials. One of the horror stories reported was in a study listed on the database but was neither FDA approved nor did they even have the right documentation to carry out a trial! Does clinicaltrials.gov need red flags, it’s own review committee?