There has been a steady stream of encouraging data on stem cells for MS. Particularly for certain kinds of MS.
A new study adds to this upbeat direction.
Good news on stem cells for MS
Haematopoietic stem cell transplantation for treatment of relapsing-remitting multiple sclerosis in Sweden: an observational cohort study, Journal of Neurology, Neurosurgery, and Psychiatry.
This paper is consistent with the results of other groups that HSCT looks to have a major benefit for some MS patients. The authors here conclude, “Treatment with aHSCT for RRMS is associated with freedom from disease activity in a majority of patients, with acceptable adverse events. This procedure should be considered a standard of care for patients with highly active RRMS.”
Imagine if stem cells for MS become the proven standard of care for many cases. It’d be so amazing. I know some physicians particularly outside the U.S. already view it that way.
Kimera Labs IND for COVID
Kimera Labs, which manufactures exosome products, got some good news from the FDA back in May. The firm received its first cleared IND, in this case for an investigational exosome therapy for COVID.
I missed this IND news, probably because I submitted three NIH grants in June/early July and had a nasty case of COVID starting in mid-June. I’ve been following Kimera Labs for a long time. It’ll be interesting to follow this IND and any subsequent trial data. This IND is particularly notable as the FDA sent Kimera an untitled letter during the worst of the pandemic related to product use for COVID.
The agency also sent a warning to Dr. Douglas Spiel for exosome use on COVID patients. Spiel had been a clinical consultant for Kimera but hasn’t had a role at the company for a few years now.
FDA – Cell Surgical Network lawsuit appeal
We’ll probably have to be much more patient on a big pending stem cell lawsuit appeal.
The FDA lost the federal district court case, here in California over the issue of whether the adipose cell product SVF is a drug and other issues. It had won a similar case in Florida.
Now the California SVF case, the Cell Surgical Network lawsuit, is with The Ninth Circuit. This one is probably going to push into 2024 before it is decided. Why? By way of update, the case listing now discusses the possibility of oral arguments in January 2024. Unless the parties can resolve the case independently of that, which seems unlikely, this case is going to take a very long time.
Why Pasadena? I thought it’d be in San Francisco.
Other recommended reads
A H3K27M-targeted vaccine in adults with diffuse midline glioma, Nat. Med. This is hopeful even if very preliminary. I found the strong response by one patient to be particularly interesting.
An FDA advisory committee rejected an appeal-type effort by BrainStorm Cell Therapeutics for its Nurown product for ALS.
I watched a little of the panel meeting and they were quite negative. They had big concerns about the data as well as unknowns about how the product was supposed to work. There was also a chance, several committee members said, that Nurown harms some patients.
In the end only one person voted “yes”, seventeen said “no”, and one abstained. I posted the vote above from the video. I recently wrote about how I saw this effort by the firm as a Hail Mary. The FDA now has until early December to make a final decision. It looks very unlikely that Nurown will move forward at this time.
Neuron has also been in clinical trials for MS and represents another possible stem cells for MS kind of approach, but the data so far there haven’t been so encouraging.