Weekly reads: stem cells for MS, Kimera Labs IND, FDA lawsuit

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.

Symptoms_of_multiple_sclerosis, stem cells for MS
Symptoms of multiple sclerosis or MS. Soon there may be a widely-approved stem cell treatment for some cases.

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.

Cell Surgical Network lawsuit
Cell Surgical Network lawsuit appeal status. Screenshot from Pacer.

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.

BrainStorm Cell Therapeutics, FDA vote
BrainStorm Cell Therapeutics FDA vote. Committee members each briefly explained their thinking including Don Kohn above.

Other recommended reads

A H3K27M-targeted vaccine in adults with diffuse midline glioma, Nat. MedThis 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.

10 thoughts on “Weekly reads: stem cells for MS, Kimera Labs IND, FDA lawsuit”

  1. I have still not seen Kimera’s IND on the clinical trials website.

    Now take a look at Vitti Labs, they have 3 IND’s in Phase II. Covid Long Haul, POI, and Covid. I like the way they do business.

    1. INDs are not generally listed on Clinicaltrials.gov. Kimera can have an IND and there may be no public indication of that unless the firm chooses to announce it. The FDA generally considers INDs and related information to be confidential unless sponsors choose to make it public.

      How do you know Vitti Labs has 3 INDs? Clinicaltrials.gov listings do not mean a sponsor necessarily has an IND.

      Also, Vitti Labs received an FDA warning on July 28, 2022: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vitti-labs-llc-627699-07282022

      The warning said amongst other things, “nor is there an IND in effect for your products.”

      Yet a couple of months before this warning, there is a press release that says that Vitti Labs says they got an IND.

      So what’s going on? It’s not clear.

  2. No mystery. Pasadena is the home of the Ninth Circuit, in an old resort hotel on the edge of the Arroyo Seco. The Circuit, which includes 9 states and several territories, has many courthouses and can hear cases in many cities. It regularly hears cases in four of them: Seattle, Portland, San Francisco, and Pasadena. It usually schedules cases for hearing based on the geographical location of the district court from which the case was appealed. This case came from the Central District of California’s division in Riverside. Presumably the plaintiffs filed the case there thinking it was a good location for them. The Pasadena courthouse is only about an hour’s drive from Riverside.

  3. Paul I know you’re very skeptical but…

    There is one lady, and I’ve interacted with her on Twitter, who has MS who tried every single medication there is for MS here in the USA, and nothing worked. Her MS was continuing to get worse and none of the medications her doctor’s here in the u.s prescribed her worked. And of course some of the medications she took gave her really harmful side effects, If I remember correctly she said one of the medications made her extremely ill.

    Then she went to the Stem Cell Institute in Panama and got an infusion of umbilical cord derived mesenchymal stem cells and it made all of her symptoms of MS disappear. She goes to Panama about once a year for an infusion of umbilical cord MSCs, she believes this is the only thing keeping her MS at bay.

    And remember here in the USA the doctor’s prescribed her all sorts of medications but none of it worked and some of it made her very ill. And indeed some of the medications that doctors will prescribe for MS have warning labels warning you that this medication could possibly kill you.

    Why take medication with a warning label that it might kill you when you can fly to Panama and get umbilical cord MSCs?

    Why do people have to go to Panama for umbilical cord MSCs? When will the FDA finally approve umbilical cord MSCs so people don’t have to travel overseas to get it?

    Her name is Holly Huber, like I said I’ve interacted with her on Twitter before. She tried every single medication there was for MS and none of it worked. https://youtu.be/gCVlvq7euek?si=mWLZAjcRUfSb3vl7

    I am truly convinced that umbilical cord/placenta derived mesenchymal stem cells will revolutionize modern medicine. Exosomes too.

    So what makes umbilical cord MSCs so special? It’s because they are extremely young, these are extremely young stem cells. Not old but young. You don’t want old cells you want young cells.

    1. Jake,
      Might they work? Sure. But the problem is there has been no clinical trial with appropriate controls done to give evidence. And the Panama clinic makes very bold claims. Since they charge money, they have a financial interest in publicizing any real or perceived positive outcome, and to downplay or dismiss (or just not report) any negative outcome. Anecdotal reports are not medical science, and they have been shown over the decades and centuries to sadly be worth very little.

      Medical Science requires robust testing to show safety and efficacy. Testimonials do none of this.

      1. I read Dr Neil Riordan’s book, he tells you how these people were in the USA and they were suffering from rheumatoid arthritis or MS for example, and they literally tried every single medication there was and none of it worked, and some of the medications even made them very sick because some of the medications for MS and rheumatoid arthritis can have some really nasty side effects.

        So they tried everything that Western medicine had to offer and nothing worked for their rheumatoid arthritis or MS. Until they came to Panama to get infusions of umbilical cord MSCs. He tells you these people’s names and their stories.

        Holly Huber’s story is in Neil Riordan’s book and I’ve even interacted with her on Twitter before. She has MS and she literally tried all the medications that American doctors would prescribe her for MS and nothing worked and her MS was continuing to get worse and worse. And then she goes and gets umbilical cord MSCs in Panama and it essentially made all of her symptoms go away. Here’s Holly Huber in her own words


        Paul actually admitted to me on twitter that he thought umbilical cord MSCs would probably eventually get approved for something. Who knows maybe that something will be MS or rheumatoid arthritis? Or even congestive heart failure?

        please follow this link and start watching at 29:30 this is a case study of a patient who had end stage congestive heart failure and went to Panama to get umbilical cord MSCs and essentially made a full recovery. Before this patient got stem cells in Panama he had an ejection fraction of 16 to 20% and after getting stem cells his ejection fraction went up to over 39%. They even show you an echocardiogram of his heart before and after getting stem cells.

        https://youtu.be/55zrTTgnWwE?si=nkDJba1bSfe-g0kC Please watch this?

        I think someday it will eventually be proven beyond a doubt that umbilical cord MSCs really can cure congestive heart failure. I think it’s inevitable, that eventually the FDA will approve umbilical cord MSCs.

        1. @Jake,
          The standard in the medical field is to publish your clinical trial results in peer-reviewed journals, don’t charge for something in advance for proving it works and is safe, stop selling something if your published results are not convincing, etc. and the list goes on. Many people operating stem cell clinics in the US and elsewhere don’t follow these principles and rigorous scientific and clinical trial standards. A book or YouTube video is not a substitute for rigorous clinical trial data published in good journals.

          1. “Before this patient got stem cells in Panama he had an ejection fraction of 16 to 20% and after getting stem cells his ejection fraction went up to over 39%. They even show you an echocardiogram of his heart before and after getting stem cells.”

            That doesn’t hold any weight with you? Dude his ejection fraction was below 20% and after getting umbilical cord MSCs went up to over 39%.

            But yeah the data is coming, the clinical trials are currently happening as we speak. But I’m hearing from multiple clinics, not just the clinic in Panama, I’m hearing from multiple clinics anecdotal stories that umbilical cord MSCs are literally curing congestive heart failure in patients.

            You know people who are dying from congestive heart failure have no choice but to get a heart transplant, it’s a fatal disease.

            Recently the FDA said it was ok to implant genetically modified pig hearts into humans, the FDA said this was ok

            Well… Why isn’t it ok to intravenously inject someone with umbilical cord MSCs who is dying from congestive heart failure? What’s the risk? You don’t think the pharmaceutical industry fears what MSCs could do to their profitable business, which is pushing pills? Do you realize that the pharmaceutical industry has influence over the FDA?

            Almost every single FDA administrator goes on to work for the pharmaceutical industry (where they get paid huge salaries) after their time at the FDA, talk about conflict of interest.

            Ok, so do you know how Oxycontin got approved by the FDA? Oxycontin got approved because of bribery. Oxycontin is literally heroin in a pill. There was one guy in the FDA who could give the green light to oxycontin but he refused because he knew it was heroin in a pill, so the pharmaceutical company that wanted to get this drug approved took this guy to a hotel for 2 days, they were in a hotel room for 2 days, no one knows what happened in that hotel room, but after they took this guy to a hotel for a couple of days, the guy then went and gave the green light to oxycontin. Then he quit his job at the FDA and went on to work for the same pharmaceutical company where they paid him a huge salary. Talk about conflict of interest. Talk about corruption.

            So believe it or not Netflix made a documentary about this called Painkiller, I suggest you go watch it. Or at least read about it, unless you already knew about it?

            Oh did you already know the story about how Oxycontin got approved by the FDA? The corrupt FDA I should say.

            I’m truly convinced that umbilical cord/placenta derived MSCs and exosomes will completely revolutionize modern medicine as we know it.

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