I acknowledge the risk buying in before p3. But if p3 CLBP is successful IMO patients will be lining up considering the interest the New Scientist article has garnered on fb. Andy Coghlan (NS journalist) said in an interview with Penny Sarchet and Sam Wong posted on fb 3 months ago that MSB had already treated 280 patients and were in discussion with the FDA to maybe get an interim report out early this year.
Good science, though, means little unless attitudes in medicine change. Just five years ago the idea that the body could cure itself was rejected out of hand. Borody's work on fecal transplant for IBD has now been accepted by mainstream medicine. There's interest in using FMT for other conditions and last time I checked Borody had funding for Parkinsons. Lateline did an interesting piece on him: Curing the Incurable.
Stem cells IMO fit nicely with this new way of thinking. Wellington Hsu, a top orthopedic surgeon, said in Spinal News International 20/9/17 the more feasible mechanism seems that the stem cells allow the body to regenerate tissue itself (rather than integrating into the tissue) as SI said 5 years ago. WH suggests that because of the hostile environment of the spine (lack of direct blood flow and nutrients), stem cells might be a good application because of their ability to create a micro-environment and proliferate themselves.
I can't see CLBP patients wanting to take a drug anyway. They seem to like the idea of something that 'works with the body' and they're already going to clinics for autologous treatments.
There aren't many studies in humans and the couple I found were autologous. Orozco et al conducted a pilot study of 10 patients for DDD. Results showed 9/10 improved and had significant reduction in pain. While there was no difference in disc height, there was increased water content at one year. Pettine et al conducted a pilot study in 26 patients and all subjects had substantial reduction in pain.
Houdek et al reviewed studies using autologous stem cells for a horrific condition called avascular necrosis of the femoral head (surely also a hostile environment). AVN patients tend to be younger and the disease progressive. Authors concluded autologous stem cells showed promise in halting the condition and preventing patients from undergoing total hip arthroplasty.
Not everyone, though, will be a candidate for autologous treatment as potency and prevalence of MSCs decline with age and chronic illness; one AVN study reported poorer results with patients who had been exposed to corticosteroids and alcohol.
Another big change is that medicine is acknowledging the dangers of corticosteroids, at least in autoimmune diseases. This is the most dangerous drug to take long term above the biologics and the chemo drugs. Steroid injections have also come in for fierce criticism (Google Regenexx, 'Say no to steroids') While Centeno of Regenexx (autologous treatment) has been a vocal critic of MSB, IMO he's done a lot to pave the way for stem cell therapy. I agree with a lot of what he says about steroids and also about diet and NSAIDs such as Celebrex. Note the comments on his blog from people saying steroids made their condition worse. Personally I've seen two different cases of autoimmune illnesses in my immediate family get far worse because of steroids.
While it's important to highlight the opioid epidemic IMO MSB's candidate should be pitted against steroids. In 2015 Chou et al concluded the benefits were small and not sustained. Surely all MSB have to do is show their candidate is not worse than steroids.
One thing, though, that did surprise me when I read Coghlan's piece was the MRI evidence that MSB's cells seem to rebuild the disc. That seems stronger than I remember. My understanding from reading Centeno 's blog is that MRIs are not a good indication and that it's all about chronic inflammation. Inflammation causes pain and pain reduction is the end point anyway. Whatever the case, if MSB has strong MRI evidence for p3, the market will like it.
I drew attention to Feuerstein's take down of Athersys (where he compares the company to the Titanic) partly to show a similar style of writing that we get from MSB critics on this forum. The use of analogy in argument is inherently weak but it can be persuasive as you can leave a strong impression without explicitly stating. When facts are stated there's usually care to write what's technically accurate. The trick is to look for missing information or information that's been glossed over.
Athersys' stroke patients went on to improve one year after treatment relative to placebo. Feuerstein makes use of the Titanic analogy when dismissing this point. But if I remember rightly, SI said re. back pain that patients continued to improve over time, the reason being the pro-regenerative environment (cascade) the stem cells set off. Athersys also found their candidate worked best when given within a certain window (36 hours after stroke). MSB's aGvHD candidate works best when given right after steroid failure. IMO it's interesting (and reassuring) to see similar findings across the technology itself, which was being dismissed altogether not that long ago.
Finally the cost of stem cell treatment for CLBP has been mentioned. Why should patients accept cheaper steroid injections if they've been proven ineffective and could make them worse? Surely they have the right to see if MSCs halt the progression of their disease. The cost of any new treatment should be compared with spine fusions.
Hsu said that if MSB p3 fails to show a difference to placebo, he reckons it's five, ten, fifteen years before we see another product come about. IMO if p3 is successful, there'll be such a clamour the issue could be whether the company can meet demand.
Please free to correct any errors as I'm a layperson writing from a patient's perspective.
All IMO. Good luck to all holders
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