Three Patients Blinded by Stem Cells?

POSTED ON 3/22/2017 IN Regenerative Medicine Education BY Christopher Centeno

If you're a regular reader of this blog, you know I've frequently lamented that the wild west of stem cells has grown out of control. Every day, we see a new doctor somewhere offering this or that treatment for just about every disease described by mankind. Most of it makes little sense. For someone who has been involved in treating orthopedic patients with stem cells for 12 years, it's been disturbing to see. This past week, the awful news was reported that three consecutively treated patients were blinded by having fat stem cells injected into their eyes. It was also reported that the treatment protocol for this medical misadventure had been approved by ICMS, an organization I helped start way back when? Yikes!

A Long Time Ago...

Many years ago, I helped found an organization called the ICMS (International Cellular Medicine Society). The idea was to have a group of doctors who would all agree to strict standards for the use of stem cells. These guidelines included many of the same tenants we eventually adopted at Regenexx. To name a few, these included using a treatment registry, publishing results, and making sure new therapies had reasonable evidence before use in patients.

Sometime around 2012, it was evident to me that despite my attempt with ICMS to get all of the physicians who were using stem cells at that time to adhere to strict standards, it was like herding cats. I moved on and left the organization, and it mostly cratered after that, only existing as an IRB. Eventually, a few high-quality people stepped in to keep the flame alive (Reed Davis and David Harshfield, MD). They cleaned up the IRB after an FDA audit (after I left) had identified a few issues and subsequently went through a successful audit with a clean bill of health.

The Eye Stem Cell Study

It was a surprise to me to see reported that the eye stem cell study that ended in disastrous results was "approved" by the ICMS IRB. As usual, the reporters got it wrong. Based on a statement on their website, an entirely different treatment protocol was used in these patients than the one that was approved by the ICMS. In the ICMS-approved protocol, only one eye was to be treated, and that eye had to be legally blind for the patient to enter into the study. In addition, no patients were ever enrolled into the ICMS-approved study, so ICMS has little to do with these three patients who were treated. Hence, be careful what you read, as it usually has an agenda.

Would I Have Approved the Eye Study Had I Been on the ICMS IRB?

One of the problems I noted while on the ICMS IRB was that we would get treatment protocols that didn't have an animal model that supported that using a particular type of cells would help the condition. At the time the eye study was reviewed by the ICMS IRB, I wasn't a part of the organization. However, given that I voted against studies that didn't have an animal model, I would have voted against approval for the safer eye study that ICMS later approved and that was never enrolled. This decision is because no animal model existed at the time that demonstrated that injecting fat stem cells into eyes with macular degeneration would be helpful.

Why a Stem Cell Product Is a Bad Idea

At Regenexx, we've always viewed autologous stem cells as a medical procedure. We view it this way because your cells transplanted from one part of the body to another requires getting them out and putting them back, which requires medical skills. Hence, the doctor has to have a basic level of training and then receive further training. Regrettably, the group that treated these three consecutive patients didn't have those same requirements. In this case, a nurse practitioner was asked to inject stem cells into the eye. This is despite the ICMS only approving a board-certified ophthalmologist to perform the injections. Why? From speaking with my ophthalmology colleagues, this is a very technically challenging injection to perform, one where millimeters matter. So this wouldn't be a procedure that could be safely carried out by a nurse.

Stem Cell Procedures and Complications

All medical procedures have complication rates, even the most straightforward and innocuous. So the fact that complications occurred in any stem cell procedure shouldn't be news as long as the patient consented properly and the overall risk of the procedure was about the same as or less than other conventional medical procedures. This obviously wasn't the case with this eye-treatment protocol as three consecutively treated patients experienced an adverse outcome. This was despite the fact that intravitreal injections in the eye usually have a low complication rate.

The upshot? It's awful and personally upsetting to see three patients blinded by a medical misadventure. In the end, while I wouldn't have personally voted to approve a study where fat stem cells were injected into a patient's eye, the protocol that was approved by ICMS was solid in that it required the patient to be legally blind to get the injection in only one eye. Therefore, if the worst happened (as it did), the patient would have experienced very little overall change in their condition. As I've always said, it's crazy out there, so be careful. Nurse practitioners and physician assistants shouldn't be performing complex surgical procedures, like bone marrow aspiration, liposuction, or injecting stem cells into your eye.      

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