Sunday, May 5, 2019

Stem Cells for Stroke: Expensive, Unproven and Unavailable.


I'm not a big fan stem cell treatment to help stroke recovery. 

Not yet anyway.

Part of the problem (bluntly) is the surgery.  A hole is drilled through the skull— and that's the least invasive part of the procedure. 
Through that hole, a long needle is directed (multiple times) to the area around the stroke (infarct) in the brain. 

Remember: the stroke kills part of the brain. After the stroke, that dead area "cavitates"— literally forms an empty cave in the brain. Nature hates a vacuum and the cavitation is a vacuum. So it doesn't remain empty— it fills with cerebral spinal fluid (the fluid that flows in, through, and around the brain). That fluid-filled area is dead, and no amount of stem cells, or any other sort of treatment is going to bring those dead brain cells (neurons) back. 

Stem cells treatment aims to overcome the loss by injecting stem cells in the survivor's brain, just outside of the area that was killed. 

Those cells will then turn into brain cells (neurons). That's the idea, and it does hold tremendous promise. And they will get it right, one day. But that day ain't yet. 

A study that is often cited as a seminal stem cell/ stroke study is entitled Clinical Outcomes of Transplanted Modified Bone Marrow–Derived Mesenchymal Stem Cells in Stroke. This study, done at Stanford and one other site, enrolled a total of 18 patients. 

The study has 3 problems: 
1. No control group. 
2. A Lot of people screened, few qualified. 
3. The data (for the primary movement test they used, at least) appears underwhelming.

No control group. 
Everyone got the treatment. Not great. Because with no control, everyone doing the data collection knew that everyone got the treatment. Uncontrolled studies like this put tremendous pressure on the folks who are measuring progress. If the scores go down, the whole study looks bad, which can affect future funding. So there's a tendency to want to "cheat" the score up, either consciously or unconsciously.

A Lot of people screened. Few qualified. 
379 stroke survivors were considered (screened). And out of those 379, only got 18 the qualified. Why was the qualification ratio so low? It's hard to say. According to the data supplement available with the study, they had a lot of "exclusion criteria"— things that might keep people from the study. But, it is a pretty basic list of exclusions for a stroke study. So why were so many people turned down? Maybe they weren't. Maybe potential participants refused be be enrolled. Why would they refuse? Let me explain...

In research you have to do what's called "informed consent." You have to tell the participant (or the less modern term "subject") every aspect of every aspect of the study that pertains to that participant. This is a federal and international law. Why is it so important to inform participants? Let's put it this way... the Nazis did not inform Jewish (and other) prisoners of the experiments the prisoners would be involved in. And, really, nobody wants be a Nazi. 

But it wasn't just the Nazis. Consider the U.S. Public Health Service Syphilis Study at Tuskegee, a horror show that withheld life saving treatment from African American men so  "scientists" could track the "natural progression" of syphilis.  That didn't end until 1972!

The upshot were a whole bunch of very strict rules when it came to human participants. We now have to tell any potential participant EVERYTHING that may affect them in the study. This process— the process of explaining everything, again, is called informed consent.

OK, back to stem cell research and why I think they had a lot of people run out of Stanford as fast as they could.

During informed consent, the participants were probably shown the needles that would go into their brain. They'd probably also were informed that there would be some brain damage as the needle tore through brain tissue on the way to the target. 


The data appears underwhelming.
This study had one primary way of measuring movement: A test called the Fugl-Meyer. I did this test for 12 years straight, every day, often multiple times a day. I think I've done it more than anyone in the Galaxy.

Bottom line, there wasn't much of a change. Just over 11 points. That's 11 points out of a possible 88. This is a relatively modest increase. It is true, modest increases may make a huge difference. But 11 or 12 points can be potentially garnered by being able to straighten the elbow a little more.

But the authors ride it for all its worth. This is unfortunate because scientists have a hard enough time explaining their science to the world without the added burden of  exaggeration.

We did not expect to see significant recovery. We were quite startled by the remarkable recovery some of the patients showed.” I could get more points than that using intensive repetitive practice-- and without the pesky brain needles. And please! Stay away from the term significant! Significant means one thing in the world of scientific statistics, but to laymen reading your interview it means "a lot".

She was what we call one of our miracle patients." [sic] There were only had 18 "patients." How many miracles were there? 


We all want something that works. But stem cell therapy isn't there yet. What is weird is that this study does have important findings that move the science forward. Establishing safety across multiple parameters (as this study did) is important. 

Please note that stem cell therapy for stroke recovery is not available in the US or Europe, except in clinical trials. However, I know a survivor who had a series of stem cell treatments for his stroke. This was over the years  2013- 2015 in Thailand and China. You can find info about this option here:

https://beikebiotech.com http://thebrightdirection.com/stem-cell-treatment/stereotactic-brain-surgery/ http://www.wumedicalcenter.com

This survivor reports that he thinks the treatment cost ~16k USD.

2 comments:

Geoff.Wenker said...


Peter,
You are talking about Phase 1 of SanBio clinical trial and your comments are spot on. I studied the Phase 1 results, because I applied for the Phase 2 trial "Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (ACTIsSIMA)" with 156 participants. This is the link https://clinicaltrials.gov/ct2/show/NCT02448641 I applied in 2016 and was accepted in 2017. The screening testing & MRI was on 05/01/17. After that, the procedure was on 07/13/17. The waiver & consent form was extensive. 8 Follow up visits for MRI's and testing took a year and I completed the trial 06/04/18. I had no improvement and do not know whether I was in the placebo group yet. That will be interesting, if they ever publish the results. I can't imagine what the company is spending on this trial. Personally, I am skeptical, but if it works that might help a lot of people. I have no regrets and it was quite an experience.

Geoff.Wenker said...

Peter,
You are talking about Phase 1 of SanBio clinical trial and your comments are spot on. I studied the Phase 1 results, because I applied for the Phase 2 trial "Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (ACTIsSIMA)" with 156 participants. This is the link https://clinicaltrials.gov/ct2/show/NCT02448641 I applied in 2016 and was accepted in 2017. The screening testing & MRI was on 05/01/17. After that, the procedure was on 07/13/17. The waiver & consent form was extensive. 8 Follow up visits for MRI's and testing took a year and I completed the trial 06/04/18. I had no improvement and do not know whether I was in the placebo group yet. That will be interesting, if they ever publish the results. I can't imagine what the company is spending on this trial. Personally, I am skeptical, but if it works that might help a lot of people. I have no regrets and it was quite an experience.

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