CompletedPhase 1Phase 2Progressive MSNCT04823000

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Rildinadstrocel

What it measured

Main measures

  • Appearance of adverse events

    48 months following first treatment

    Safety
  • The changes in Expanded Disability Status Scale (EDSS) score 0-10 scale, higher scores show worsening of disability)

    48 months

    Disability progression

Other measures (4)

  • Changes in the percentage of CD4/CD25/FoxP3 triple positive stained cells (T regulatory cells), following MSC-treatment

    up to 6 months

    Immune response
  • Changes in the percentage of CD3+CD69+ cells (activated lymphocytes), following MSC-treatment

    up to 6 months

    Immune response
  • Changes in the percentage of CD11c+/CD86+/Lin- cells (dendritic cells and antigen-presenting macrophages), following MSC-treatment

    up to 6 months

    Immune response
  • Changes in the proliferation ability of mononuclear cells to PHA, following MSC-treatment

    up to 6 months

Who could take part

Progressive MS · 18 to 65

Inclusion Criteria: 1. Consenting patients fulfilling the Poser's criteria for definite MS 2. Age 18-70 3. Male and female 4. EDSS rate 5.5-7.5 (moderate to high disability) 5. Failure to two lines of the currently available registered immunomodulatory treatments for MS. The lack of response to these treatments was determined by either an increase in EDSS or the appearance of at least two relapses of MS during the year prior to inclusion. Exclusion Criteria: 1. Patients who were treated with cytotoxic medications during the last three months prior to the infusion. 2. Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results. 3. Patients with active infections. 4. Patients with cognitive decline or inability to understand and sign the informed consent.

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

About this trial

In the sponsor's words

An open prospective study with multiple (every 6-12 months) intrathecal or intravenous injections of autologous MSC in patients with progressive forms of MS (secondary progressive, primary progressive or relapsing-progressive), who failed to respond to first and second lines of immunomodulatory treatments and deteriorated (at least 0.5 degree in the EDSS scale) during the year preceding their inclusion to our study or had at least one major relapse without sufficient recovery.

Papers

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Related trials

History

    1. Started

      Jan 2013

    2. Main results due

      Dec 2016

    3. Finished

      Apr 2020

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