Second site begins enrolling patients in BrainStorm ALS trial


The University of Massachusetts Memorial Medical Center in Worcester is now enrolling patients in BrainStorm Cell Therapeutics' (BCLI +0.8%) Phase 2 clinical trial evaluating the safety and efficacy of NurOwn in ALS patients. The medical center is the second of three sites participating in the 48-patient trial. Mass General started in June and the Mayo Clinic will come on line in Q3.

NurOwn is an autologous adult stem cell therapy that differentiates bone marrow-derived mesenchymal stem cells (MSC) into specialized neuron-supporting cells.

The study's primary endpoint is the safety of intrathecal and intramuscular injections of NurOwn. Secondary endpoints are efficacy-related (change in slow vital capacity and change in ALS Functional Rating Scale).

Related ticker: (CUR -3.2%)

Comments (5)
  • upwithpeople
    , contributor
    Comments (49) | Send Message
     
    Intramuscular injections are a joke. BCLI will need to demonstrate efficacy beyond the three months they can show with intrathecal treatment. No payor is going to pay for quarterly treatments.
    15 Jul 2014, 11:11 AM Reply Like
  • jayemel
    , contributor
    Comments (16) | Send Message
     
    Unless and until any therapeutic intervention can be shown to offer increased efficacy in improving the lives of patients with such a disease as ALS, I can assure you that payors will most certainly pay for quarterly treatments, once they are proven to be beneficial. This will be done not out of generosity or in the name of humanitarianism, but strictly from a cost-benefit analysis. Since there are currently no available remedies to alter the progression of this devastating disease, the cost of care for its victims is likewise progressive, until death ends the payment of insurance premiums.

     

    Up with BCLI
    15 Jul 2014, 01:20 PM Reply Like
  • upwithpeople
    , contributor
    Comments (49) | Send Message
     
    That's very touching, really, but ultimately incorrect.

     

    Insurance companies are not going to pay for quarterly cell collection and expansion, spinal taps, and repeated hospitalizations. Be mindful that these procedures are also painful for the patients, who will question the value of repeated ordeals of this nature. Not to mention the risks of infection, CSF leaks, etc., etc.
    The cost of care is not progressive...
    They will need to demonstrate efficacy beyond a few months. This is a sad but obvious fact. I hope they do.
    16 Jul 2014, 09:17 AM Reply Like
  • BigPapa
    , contributor
    Comments (11) | Send Message
     
    It was my understanding that they only need to extract the cells once, then they can grow and store them for future injections.
    16 Jul 2014, 12:29 PM Reply Like
  • upwithpeople
    , contributor
    Comments (49) | Send Message
     
    That is possible, but as cells are expanded, they undergo many of the same processes as a normally aging cell. They are not identical. It is unknown whether the cells would maintain the same integrity or efficact after many divisions.
    Either way, quarterly spinal taps for cell injections is not an optimal solution.
    17 Jul 2014, 09:20 AM Reply Like
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