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Stem cell study fails, again, to live up to the billing

Posted on May 4, 2026 by
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Stems cells have been sold as the saviour for people with MS, but many decades on and I am still waiting to see the great results after all the Hype.

Sadly there are a load of chancers who want to take your money and feed into the hype and They can take some cells and call them stem cells and then they take your cash with no guarentees. So it is as every buyers beware.

There is a stem cell therapy what works and that is hamatopoeitic stem cell therapy. He you take blood and you make embroyic stem cells that can replace your immune system. You ablate the current immune system and then give stem cells to make a new immune system. This works and if there is not too much damage and progression. There is know doubt it can do wonders. I watch the video of one of the regular posters on the blog, when they do a yearly post as they run round Portugal, I can’t even do that am I haven’t got MS or at least I don’t think I do.

However then there is the seeder side of stem cell research and yep you have the charlotan Neuros ready to take your cash…but I have to say we researchers has fed into that hype. There are labs that have got alot of money for doing stem cell research that must be said has gone nowhere fast. I once had a grant to do some work on stem cells and I have to say it is the only grant that I stopped early because I didn’t think it was going to go anywhere. Many years ago I watched a channel 4 documentary of people going to the Middle east to get their mesenchymal stem cells injected into the spine. After an initial perception of change, some may say placebo effect, the treatment didn’t work. There have been MS Society trials in mesenchymal stem cells and they have not been great. Here we have another one from Norway. It is another MS-SMART trial….Just like the UK MS-SMART trial looking at statins not stem cells…the trial was actually not MS-NOT-SO-SMART because the study failed.

Hower the aim of these stem cells is to aim to repair and replace the damage, it is a very different ask to do this. You are replacing your immune system all the time, but the nervous system is designed not to be replaced, what is lost is typically lost. In my mind the pre-clinical animal data was very weak and the positive results were largely immune inhibition and not repair. Indeed most cells never got into the CNS. Importnat I could put any number of drugs into the same situation and one could easily get better results…I am not convinced the data is good enough.

So here you stick them into the CNS as a direct delivery but how do you control what they are going to become, you want them to make? New myelin or do you want them to become new nerves? It’s sad when things fail. How this is a small trial and sadly it is too small to get much besides a “I told you so” vibe.

Kvistad CE, Kråkenes T, Holmøy T, Eidem LE, Steffensen L, Wesnes K, Rojewski M, Eichele T, Wergeland S, Gavasso S, Barsnes H, Assmus J, Al-Sharabi N, Mohamed-Ahmed S, Vrenken H, Brouwer I, Mutsaerts HM, Tranfa M, Gjerde C, Ytterdal M, Rødahl E, Berven FS, Schrezenmeier H, Mustafa K, Bø L. Intrathecal Mesenchymal Stem Cells in Progressive Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial (SMART-MS). Neurology. 2026 May 26;106(10):e214915. doi: 10.1212/WNL.0000000000214915.

Background and objectives: There is an unmet need for neuroregenerative therapies in multiple sclerosis (MS). Mesenchymal stem cells (MSCs) have shown immunomodulatory and regenerative effects in preclinical models and early clinical studies. Intrathecal administration may enhance therapeutic potential by direct delivery to the CNS. However, randomized, placebo-controlled trials are needed to establish safety and efficacy. The objective of this trial was to assess whether a single intrathecal administration of autologous MSCs could provide evidence of a neuroregenerative effect in progressive MS.

Methods: In this randomized, double-blind, placebo-controlled phase I/II trial (NCT04749667), patients with progressive MS enrolled at 4 Norwegian tertiary hospitals received a single intrathecal injection of autologous bone marrow-derived MSCs (1 × 106 cells/kg) in a crossover design. The primary end point was the change in latency of combined evoked potentials at 6 months. Secondary end points included safety, brain MRI measures, functional and ophthalmologic assessments, and serum biomarkers at 6 and 12 months. Exploratory analyses comprised proteomic profiling of CSF. Outcomes were analyzed using baseline-adjusted regression models.

Results: A total of 18 patients were included (mean age 46.7 years; 55.6% female). No significant between-group difference was observed for the primary end point (β = -0.31, 95% CI -1.84 to 1.22, p = 0.668). At 6 months, patients in the MSC group showed reduced cerebral atrophy on MRI (β = 9.37, 95% CI 0.29 to 18.45, p = 0.044) and lower serum glial fibrillary acidic protein levels (β = -16.3 pg/mL, 95% CI -33.0 to 0.3, p = 0.054), but neither were sustained at 12 months. Exploratory CSF proteomics revealed reductions in multiple inflammation-related proteins at 6 months. One serious adverse event was deemed probably related to MSC treatment. Common adverse events included fever (n = 9) and low back pain (n = 10) after MSC administration, and spinal MRI abnormalities with fluid loculations and nerve root clumping (n = 7) at 6 months. One patient developed chronic coccygeal pain attributed to arachnoiditis.

Discussion: A neuroregenerative effect was not detected, although interpretation may be limited by the small sample size. Adverse events suggest an acute localized inflammatory reaction after MSC administration. Our findings suggest that intrathecal administration of MSCs in progressive MS should be approached with caution in future studies.

Source: multiple-sclerosis-research.org

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