There has been a lot of attention about a Sutter clinical trial to use adult stem cells for the treatment of autism.
I did a post on it here. After more reading, I’m scratching my head even more about the hypothesis at the heart of that trial, but I’m no autism expert.
Emily Willingham, who knows far more than I about autism, also did a great post on this Sutter trial her blog. Emily also did a wonderful post on a deeply flawed piece in the NY Times about inflammation and autism followed up by another newer helpful piece on background for the NY Times piece on autism and inflammation.
I have some concerns about the Sutter Trial for stem cells for autism including the fact that the underlying hypothesis related to inflammation may well be fundamentally wrong. Even if it were right, how exactly would the stem cells help? Would they have to get in the brain? How? Where would they go from there?
But beyond practical science issues, another element to this story that is of serious concern is that the Sutter trial is already having unintended, negative consequences.
The Sutter Trial is indirectly lending credence to dubious, for-profit stem cell clinics in Latin America offering similar treatments on a for-profit basis for the treatment of autism. The folks running these clinics are already citing the Sutter trial as support for their dubious claims and exploitive ways.
So as the Sutter trial proceeds, at the same time it is likely to end up indirectly leading to more kids getting dubious stem cell treatments for autism in Latin America.
This kind of dark echo of an FDA-approved clinical trial in the U.S. leading to non-approved dubious, for-profit treatments increasing outside the U.S. may be a phenomenon that occurs more generally.
Still we need clinical trials, even higher risk (in the sense of likelihood of success, not safety risks) ones such as this Sutter stem cell clinical trial for autism, so what do we do if dubious for-profits exploit trials to try to drum up business at their clinics….especially if the treatments target children?
Solutions?