CompletedPhase 2NMOSDNCT02249676

What it found

No result found

We found no results in the registry or in papers.

This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Rildinadstrocel

What it measured

Main measures

  • EDSS

    change from baseline to one year

    Disability progression

Other measures (6)

  • Annual relapse rate

    1 year after infusion

    Relapses
  • Lesion load

    1 year after infusion

    MRI lesions
  • Retinal nerve fiber layer (RNFL)

    1 year after infusion

    Retina scans (OCT)
  • Cognition

    1 year after infusion

    Thinking and memory
  • Immunological assessments

    1 year after infusion

    Immune response
  • cerebral volume

    1 year after infusion

Who could take part

NMOSD · 18 to 80

Inclusion Criteria: * Clinically definite neuromyelitis optica or neuromyelitis optica spectrum disorder * Age > 18 year * EDSS > 3 * Progression continued relapses or worsening MRI after at least a year of attempted therapy as evidenced by one or more of the following: * Increase of 1 EDSS point (if baseline EDSS\<5.0) or 0.5 EDSS points (if baseline EDSS >5.5) * Moderate-severe relapses in past 18 months * Gadolinium enhancing lesions (double or triple dose Gd) * 1 new T2 lesion * Evidence of recent inflammatory disease, as evidenced by any one of the following: * 1 moderate-severe relapses in past 18 months * 1 Gd-enhancing lesions (single, double or triple dose Gd) * 1 new T2 lesion Exclusion Criteria: * Received Immune inhibitors immunomodulator during the three months before the trial * Significant cardiac, renal, or hepatic failure or any other disease that may affect the results of the study * Allergies * Pregnant or possibly pregnant * Cognitive decline to understand or sign the informed consent * Brain tumor, HIV (+) tumor marker (+), blood pressure (BP): 200 /110 mmHg * Judged not suitable by doctors

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Neuromyelitis optica (NMO) is a demyelinating and degenerative disorder of the central nervous system affecting vision and brain and spinal cord function which leads to accumulating disability with a 5 year-mortality of approximately 30%. Survivors are typically left with severe morbidity secondary to blindness, quadriparesis and respiratory failure. No agent has been found to be highly effective in halting disease activity.Based on recent outcomes of Multipotent mesenchymal stromal cells in autoimmune diseases including multiple sclerosis, and based on the mechanisms of neuromyelitis optica, the investigators anticipate that mesenchymal stem cells transplantation may provide lasting disease stability for neuromyelitis optica patients.

Papers

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    Related trials

    History

      1. Started

        Jan 2013

      2. Main results due

        Dec 2014

      3. Finished

        Dec 2014

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