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Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis

Phase 2 Trial to Investigate the Clinical Efficacy & the Optimal Administration (Based on the Immunological, Clinical & Neuroradiological Effects) of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis
CompletedPhase 2Progressive MSNCT02166021

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

  • Mesenchymal stem cells

What it measured

Main measures

  • Safety Assessment

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

    Safety

  • Neurological efficacy

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

    Disability progression

Other measures (15)

  • EDSS score

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

    Disability progression

  • Ambulation score

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

  • Functional scores

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

    Disability progression

  • Single injection vs. repeated MSCs injection

    12 months: ie the total duration of the trial

    Disability progression

  • Relapse rate

    12 months: ie the total duration of the trial

    Relapses

  • T2-weighted flair lesions load in MRI

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

    MRI lesions

  • Total brain volume in MRI

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

    MRI lesionsBrain volume loss

  • Gadolinium enhancing lesions in MRI

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

    MRI lesions

  • Functional MRI

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

    MRI lesions

  • 25-feet timed walking

    6 months for each treatment cycle; the two cycles (each of 6 months duration) will be combined together and provide a single measurement for each group

    Walking and mobility

Who could take part

Progressive MS · 18 to 65

Inclusion Criteria: 1. Consenting patients fulfilling the Poser's clinical criteria for definite MS 2. Age: 18-65, males and females 3. Duration of disease: >3 years 4. Progressive form of MS: PPMS, SPMS (with/without relapses) 5. EDSS score of 3.5 - 6.5 6. Failure to currently available, registered - first and second line immunomodulatory treatments (at least one). 7. Evidence for new activity of MS during the 3 months before the injection of MSC. Exclusion Criteria: 1. Patients who were treated with cytotoxic medications during the last 3 months prior to the inclusion. 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 severe cognitive decline or inability to understand and sign the informed consent 5. Patients who received any cellular treatment in the past

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

About this trial

In the sponsor's words

The purpose of this study is to evaluate the clinical efficacy and the optimal way of administration of autologous mesenchymal bone marrow stem cells (MSC) compering intravenous injection and intrathecal injection vs. placebo, in active-progressive Multiple Sclerosis patients.

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Jan 2015

    2. Main results due

      Jun 2018

    3. Finished

      Dec 2018

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