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STUDY: Long-term outcome of the Canadian MS BMT study finds "no disease activity"

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  • STUDY: Long-term outcome of the Canadian MS BMT study finds "no disease activity"

    Long-term outcome of the Canadian multiple sclerosis BMT study: efficacy and safety of treating aggressive multiple sclerosis with immunoablation and autologous stem cell transplantation

    M. Freedman, H. Atkins, M. Bowman on behalf of the Canadian MS/BMT Study Group

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    Immunoablation followed by autologous stem cell transplant(ASCT)has been studied as a potential treatment for MS. This study examined whether a long-lasting MS progression free response is induced for patients with active and progressive disease who are predicted to have a poor prognosis. The Canadian MS/BMT trial is a non-randomized phase II trial of intensive chemotherapy and CD34 selected ASCT in 24 patients considered at high risk of progression with aggressive MS who failed >=1year of standard treatment with and EDSS>=3 and <=6.

    Patients underwent stem cell mobilization following high dose cyclophosphamide(CTX)and G-CSF. Immunoablation with CTX,anti-thymocyte globulin(ATG)and adjusted-dose busulphan was followed by infusion of an ASCT graft depleted of immune cells. Patients were closely followed every 3 months for 3 years and then every 6 months, for up to 10 years with regular clinical visits, MRI’s, immunological, neuropsychological and CSF assessments. None of the patients received disease modifying medication after the ASCT.

    The first transplant occurred in October 2001 and the 24th in December 2009. The median follow-up of the group was 68 months. Serious toxicity developed in 2 patients receiving the highest dose of oral busulphan leading to a transient capillary leak syndrome in one and fatal liver necrosis in the other.

    After 1700 patient-months of follow-up, not a single patient experienced any further signs of inflammatory disease activity. The EDSS stabilized or improved in 15 patients while 8 patients experienced sustained EDSS progression in the absence of inflammatory activity. Late ASCT complications included premature ovarian failure (n=14),varicella zoster reactivation (n=7) and hypothyroidism (n=5). An initial increase in the rate of brain volume loss related to the acute effects of chemotherapy was followed by a return of the rate of loss of brain tissue comparable to reports for unaffected controls.

    These results demonstrate that rigorous treatment designed to ablate the auto-destructive immune system of patients with MS results in complete and long-term cessation of detectable CNS inflammatory activity without the need for chronic immunosuppressive therapy following the reestablishment of a protective and tolerant immune system. While some patients continued to show progression even in the absence of overt inflammatory activity, the disabilities in the majority of patients stabilized or improved. This is the first treatment ever shown to reverse brain atrophy in MS.
    Dave Bexfield
    ActiveMSers

  • #2
    This is big news. Reverse brain atrophy? Stop inflammatory disease progression? Stabilize or improve disability in most cases? And all over the long term? I can only holler so loud. But don't underestimate the size of my lungs....
    Dave Bexfield
    ActiveMSers

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    • #3
      Dave, this is SO encouraging!!!! I love that there is hope. When people say MS is an incurable disease, I always answer with "YET".

      Comment


      • #4
        The protocol needs one more thing

        Sure wish they would include physical therapy in the follow up to this treatment. I have to imagine that the people whose EDSS got worse just sat around waiting for a miracle.

        OK, the treatment is harsh. Take a year to recover, then start a year of physical therapy. It's more than just an exercise program. The therapist evaluates you, then has you do exercises targeted to improve your most debilitating weaknesses. Eventually, you get back to the point where a normal exercise program is all you need to continue improving.

        Craig

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        • #5
          This is great, unfortunately the number of patients were only 24. It's a good start but it might take a long time before anything concrete would happen.

          hopefully with CCSVI and stem cell something will happen.

          vahid

          Comment


          • #6
            Craig, I couldn't agree more. PT is critical and overlooked after this treatment. Folks sit back and expect things to be magically reversed, but that's just not the case.

            Vahid, fortunately there are nearly 1000 folks who have undergone the treatment, many in studies. The successes have been repeated again and again and again. But to date there have been no Phase 3 studies with a control arm, a critical link to getting this approved.
            Dave Bexfield
            ActiveMSers

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