CompletedPhase 1Relapsing and progressiveNCT03778333

What it found

No result found

We found no results in the registry or in papers.

This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Autologous mesenchymal stem cells

What it measured

Main measures

  • To evaluate number of participants with an adverse event related to the treatment.

    48 weeks

    Safety
  • To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.

    48 weeks

    MRI lesions

Other measures (2)

  • To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).

    48 weeks

    Disability progression
  • To evaluate effect on peripheral blood immune cell populations.

    24 weeks

    Immune response

Who could take part

Relapsing and progressive · 18 to 65

Inclusion Criteria: 1. Diagnosis of MS 1. Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months. 2. Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year. 3. Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year. 2. Age_ 18-65 years 3. Disease duration: 2-20 years 4. EDSS 3,0-7,0 Exclusion Criteria: 1. Subtype of MS not fulfilling inclusion criteria 2. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization 3. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization 4. Treatment with corticosteroids within the 30 days prior to randomization 5. Relapse occurred during the 60 days prior to randomization 6. Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year 7. Severely limited life expectancy by another co-morbid illness 8. Active or chronic severe infection. 9. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts 10. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study) 11. eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination. 12. Inability to give written informed consent in accordance with research ethics board guidelines

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

About this trial

In the sponsor's words

To assess the safety of a single dose of IV infusion of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.

Papers

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    Related trials

    History

      1. Started

        Dec 2012

      2. Main results due

        Dec 2016

      3. Finished

        Dec 2016

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