DISCLAIMER: I'm not endorsing or condemning anything that was done in this article - rather, I'm trying to review the article presented,and give my perspective (and some critiques) from a scientific standpoint.
On facebook today, I came across a news article about a man who went to Panama for stem cell injections to treat his spinal cord injury. The full manuscript, "Allogeneic and autogolous stem cell therapy combined with physical rehabilitation: A case report on a chronically injured man with quadriplegia" can be read here.
The article is a retrospective case report - simply put, it is a study with one subject that looks back at an intervention that was already done, and analyzes the results. I'm actually hoping to do this kind of study with some of my clients at Push to Walk, but that's another blog entry for another time. The case study reports on a 29 year old man with a C5 ASIA C spinal cord injury, meaning he was partially paralyzed from the neck down. He had noticeable muscle contractions in almost every muscle of his body, but they were too weak for him to do things like walk, stand, or even sit unsupported or transfer himself on his own. He went to Panama, had numerous stem cell injections over 5 weeks, came back to the US, and did 6 months of physical therapy and exercising in a gym. The results he got after those first 6 months back were discussed.
Outcomes: The subject experienced an improvement in strength in 6 of 13 upper body muscle groups, and 8 out of 9 lower body muscle groups. He also achieved 30 minutes of standing on a tilt table while maintaining blood pressure, and tolerating assisted ambulation in a body-weight support harnessed device. He did not gain the ability to transfer on his own, but "increased the amount of effort he was able to contribute to these activities." Perhaps most noticeable was that he had an increase in grip strength - his right hand increased from 5 lbs before the treatment to 22 lbs after the treatment, and his left hand went from 22 lbs before on the left to 36 after. This increase in grip strength led to him being able to self catheterize, which he was unable to do before the treatment. The subject was also significantly able to reduce his spasm medication, and moderately reduce his pain medication.
What I like about the rest of the article: the author (a physical therapist who is actually the sister of the subject in this paper) is good at pointing out that "success is not always translated from the laboratory to the clinic" when it comes to stem cell research. She also mentions that since he got physical therapy and stem cells, it is actually impossible to say whether the improvements he saw were from stem cells alone, physical therapy alone, or a combination. Were there to be a study with multiple groups - some receiving stem cells, some receiving physical therapy, some receiving both, and some receiving neither, we would be able to say with more certainty what was responsible for the gains. Additionally, she points out that Manual Muscle Testing, which was the strength tests used to assess the subject's strength in this study, is not sensitive enough to detect small changes in strength that might lead to meaningful functional improvements. (Incidentally, this is one of the things that the new evaluation system we're doing a study on at Push to Walk seeks to resolve.) The author concludes by saying that further investigation into stem cell treatments combined with physical therapy is warranted, since this one showed improvements in strength and health in somebody 7 years past injury. Since this was a case study with just one subject (and therefore just one unique spinal cord injury) we can't say that what worked for him will work for everyone, but since it worked for him, we should see if it will work for other people.
What I didn't like about the article: the author says that "almost all people that sustain a SCI will achieve some recovery of motor function...occurs in the first 3 months after the injury, but the individual can continue to improve up to 18 months after the injury." She goes on to say "...many patients with chronic SCIs do not recover strength so many years post injury with physical therapy alone." She cites one paper to back this fact up, which modern research has pretty much proven to be untrue. Some research has shown that it can take up to 30 months to reach a stable ASIA score. One only needs to look at the recent studies published by the NRN to show that people as far as 20 years post injury can experience a return of function with aggressive, high volume therapy. She also mentions it is hard to say whether the subject in the paper had a truly complete injury or not, even though she shows the results of his pre-stem cell Manual Muscle Tests in the paper, which show us he had some motor function, if only slight, in almost every muscle below his injury. This conclusively shows he was an incomplete injury to begin with - if he were truly neurologically complete, he would have had nothing below the injury!
She also says there is "not a lot of evidence for chronically injured individuals recovering motor and sensory function over 2 years post injury with any type of treatment." This, once again, has been shown to be completely false, by peer-reviewed scientific research. The NRN studies have shown this to not be true. There is also published research on NRN style therapy plus direct electrical stimulation of the spinal cord returning locomotor function, voluntary muscle control, and sensation in chronically injured individuals (4+ years post injury). She does point out there is a study of a man who went from an ASIA A to ASIA C injury from 5 to 8 years after injury by doing "activity-based recovery", but says this activity based recovery consists primarily of FES cycling (cycling on a stationary exercise bike that directly stimulates the muscles of your legs, so the muscles actually contract). Activity based recovery is (or really should be) so much more than FES cycling, and generally includes locomotor training, mobility training, balance training, significant amounts of weight bearing, and general strengthening. The author does say that activity based recovery could be a valuable component to add to the post-treatment phase of stem cell patients, but it seems the author needs a better understanding of what activity based recovery truly is.
My scientific critiques: the subject in this article hadn't done any kind of physical therapy or exercise at all since leaving his outpatient therapy after he was injured. Therefore, for almost 6 years he did nothing besides some stretching and range of motion exercises, yet the article does not state how frequently. Therefore, it is very plausible that if he had done his physical therapy and gym exercise (2 days/week of each) without stem cells, he would have seen gains.
As the author said, there is no way to know for sure how much stem cells contributed to his gains now, but if we look closer there is some evidence. The subject had function in almost every muscle of his body, and hadn't done physical therapy or intensive exercise in 6 years - this means he had lots of strength to gain everywhere in his body. Additionally, axons in the central nervous system (the wiring that lets muscles communicate with your brain and spinal cord, and vice-versa) grow very slowly - the same speed as human hair at the fastest. Therefore, it is unlikely that lots of new connections were made in only 6 months after the stem cell treatments. It seems more likely to me that the gains he made were mostly from physical therapy and exercise, and less from stem cells. Physical therapy and intensive exercise have been shown to reduce spasticity, increase strength, and in some cases, increase function.
A smarter way to approach this would have been to do physical therapy and exercise first, before ever receiving stem cell treatments, for a number of reasons. One, stem cells cost tons of money, as do plane tickets and lengthy stays in Latin America, China, or Europe. You're better off seeing what kind of gains you can make on your own before spending all that $$. Number two, once you've maximized all your abilities on your own, if you do get stem cells, then you will know how much they really helped. A lot of "stem cell tourists" get these injections after not having even attempted to regain function on their own for a number of years, then go through physical therapy or aggressive exercise, then see gains. So how do we really know that stem cells were the catalyst for those gains, and not just the therapy or exercise that someone is engaging in for the first time in years? Its basic exercise physiology that if you haven't exercised in years, then start exercising, you're going to see improvements.
In Conclusion: The biggest thing I got from this article is that this subject had no adverse health effects from the stem cells. This is a good thing because I have heard about people who have gotten worse after receiving stem cell treatments. So if anything, this case study shows us good evidence that someone 6+ years post injury can go through stem cell treatments and physical therapy and exercise with no adverse health effects. Other than that, not too many conclusions can really be drawn as to the efficacy of stem cells themselves from this case study. Yes, further research on stem cells is warranted, but they are not the only hope for regeneration after a spinal cord or other central nervous system injury anymore. I encourage everybody to stay up on their regenerative research and be aware of all the things being investigated that are offering hope to those with paralysis. And, if you ever do think about getting stem cell treatments, please make sure you've exhausted all your other options first, such as physical therapy or aggressive weight bearing exercise to attempt to make gains. While stem cells may work, there are almost always other options that could be effective that are most likely cheaper and much closer to home.
Don't search for an answer without regard to validity...
Thursday, March 7, 2013
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