Friday, 25 May 2018

Stem cell trial is Safe

Stem cells are the "buzz word" and trials abound.

This one reports that they appear safe.

However, the question needs to be posed do they work?
Are our expectations too high?


Rather than write a piece at the end, I have added to the abstract in Magenta

Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study. Fernández O, Izquierdo G, Fernández V, Leyva L, Reyes V, Guerrero M, León A, Arnaiz C, Navarro G, Páramo MD, Cuesta A, Soria B, Hmadcha A, Pozo D, Fernandez-Montesinos R, Leal M, Ochotorena I, Gálvez P, Geniz MA, Barón FJ, Mata R, Medina C, Caparrós-Escudero C, Cardesa A, Cuende N; Research Group Study EudraCT 2008-004015-35.PLoS One. 2018 May 16;13(5):e0195891. 

BACKGROUND: Currently available treatments for secondary progressive multiple sclerosis(SPMS) have limited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs) represent a promising option ("WHY?-WHAT IS THE EVIDENCE FOR A PROMISING OPTION? MOST STUDIES  REPORT THAT MESENCHYMAL STEM CELLS INDUCE IMMUNE CHANGES, AND IMMUNE CHANGES HAVE LIMITED RAPID IMPACT ON PROGRESSIVE MS. SO WHY IS THIS PROMISING"), and can be readily obtained using minimally invasive procedures.(IMMUNE CHANGES CAN BE ACHIEVED WITH MANY CURRENT DMT)
PATIENTS AND METHODS: In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy (STEM CELLS WERE FROM FAT DEPOSITS) and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x10 million cells/kg) or high-dose(4x10 million cells/kg) autologous AdMSC product and followed for 12 months (WE HAVE SEEN TIME AND TIME AGAIN THAT TRIALS OF 12 MONTHS ARE SIMPLY NOT LONG ENOUGH). Safety was monitored recording adverse events, laboratory parameters, vital signs and spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, and other measures of possible treatment effects were also recorded.
RESULTS: Thirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirty were infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were not infused because of karyotype abnormalities in the cell product (THE CELLS HAD CHROMOSOMAL). Only one serious adverse event was observed in the treatment arms (urinary infection, considered not related to study treatment). No other safety parameters showed changes. Measures of treatment effect showed an inconclusive trend of efficacy. (NO SIDE EFFECT. IS THEIR EFFICACY?)
CONCLUSION: Infusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies and probably treatment at earlier phases would be needed to investigate the potential therapeutic benefit of this technique (UGH!)


THIS STUDY SHOWS USE THAT HAVING MESENCHYMAL STEM CELLS DOES NOT CAUSE MIRACULOUS RECOVERY. THEREFORE, IF YOU ARE CONSIDEREING SPENDING YOUR HARD-EARNED CASH ON SUCH A TREATMENT, YOU NEED TO DO THIS WITH YOUR EYES OPEN AND YOU SHOULD NOT EXPECT TOO MUCH.

EXPERIMENTALLY SUCH STEM CELLS CAUSE IMMUNE MODULATING EFFECTS. SUCH IMMUNE MODULATING EFFECTS CAN BE ACHIEVED JUST AS WELL OR BETTER WITH CURRENT DMT.

THERE IS VERY LITTLE EXPERIMENTAL EVIDENCE THAT THE STEM CELLS TURN INTO NERVE REPAIR OR OLIGODENDROCYTE REPAIR CELLS. THEREFORE TO EXPECT THIS TO HAPPEN IN HUMANS WITHOUT SOME GUIDING CUE IS NOT SO LIKLEY.

11 comments:

  1. karyotype abnormalities


    Chromosome abnormality

    "A chromosome abnormality, disorder, anomaly, aberration, or mutation is a missing, extra, or irregular portion of chromosomal DNA.[1] It can be from an atypical number of chromosomes or a structural abnormality in one or more chromosomes. Chromosome mutation was formerly used in a strict sense to mean a change in a chromosomal segment, involving more than one gene"

    The term "karyotype" refers to the full set of chromosomes from an individual

    Obrigado

    ReplyDelete
  2. Phase I study are to test safety and or feasibility? Right?

    Thanks

    ReplyDelete
  3. About as much chance of success as infusing pwMS with "healing" crystals.

    ReplyDelete
  4. It never ceases to amaze me, and I'm sure you feel the same way, how much the first 3 billion years of evolution put in place.

    As to the substantive point that is made in this post it does seem to embody the degree of phase 1 versus phase 3 confusion.

    ReplyDelete
  5. MD I disagree. I think many early cells studies shown much promise in the area of mesenchymal stem cells in treatment of progressive MS. These studies are one by very reputable physicians in journal with high impact factors:

    https://jamanetwork.com/journals/jamaneurology/fullarticle/801249 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3279697/

    I think you (and MD2) are passing judgment without the being informed as MSCT do seem in early studies to help in progressive MS. There is a good presentation by Dr. Peter Connick on this topic on youtube as well if interested.

    https://www.youtube.com/watch?v=mcf4rQKpeg8

    ReplyDelete
    Replies
    1. If MD1 or MD2 review these 2 papers both mesenchymal stem cells trials show a statistical significant improvement in EDSS of close to 1 (in addition to improved other markers). No neuroinflammatory agent has ever shown this.

      Please show me a single study with a neuroinflammatory agent that actually improved the clinical outcome of a progressive MS patient? What are the "healing crystals" or "magic beans" ,MD2, neuroinflammatory agents or MSCT in progressive MS patients?

      Maybe you could ask Dr. Peter Connick or Dr. Dimitrios Karussis to do a post for an unbiased and informed opinion.

      Delete
  6. can prof g please comment?

    https://www.youtube.com/watch?v=i0m_isndqc0

    ReplyDelete
    Replies
    1. "https://www.youtube.com/watch?v=i0m_isndqc0"

      From youtube comments:

      Blind Man Rollin
      "I am a product the doctors don't want you to see, I am blind and in wEElchair and have all of the drugs the doctors wanted me to and they did not work."

      I am totally blind and wheel chair bound. This is a video showing how I maintain my independence using adaptive and mainstream technology:
      https://www.youtube.com/watch?v=U5UdnWiq0_M&t=153s

      Delete
  7. I find the style of block capital pink shouting text quite patronising and I am by now very suspicious about the way you seem to promote nothing but quite dangerous drugs on this blog, also for progressive MS. (I have progressive MS and I have yet to be convinced that any treatment currently available would help me overall, once side effects and low efficacy are weighed up.)

    ReplyDelete

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