Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

The Effect of Stem Cell Therapy and Comprehensive Physical Therapy in Motor and Non-Motor Symptoms in Patients With Multiple Sclerosis: A Comparative Study.

CompletedPhase 1Phase 2MS (type not specified)NCT03326505

What it found

Paper found, not read

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

What was tested

Treatment tested

  • Umbilical cord derived Mesenchymal Stem Cells
  • Supervised physical therapy

What it measured

Main measures

  • Isolation and Expansion of Mesenchymal Stem Cells

    3-6 months

Other measures (4)

  • Safety and Efficacy Assessment Pre and Post Treatment

    3-12 months

    Safety

  • Motor Functions Assessments

    3-12 months

  • Measuring Non-motor outcomes to assess treatment efficacy.

    3-6 months

  • Biological Assessments

    3-12 months

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

Inclusion criteria

* A clinical diagnosis of definite MS according to the revised McDonald Criteria. * Expanded Disability Status Scale (EDSS) ≤ 7 * Failure of standard medical therapy * Disease duration of at least three years prior to enrollment.

Exclusion criteria

* Pregnant and lactating women * Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment * Recent MS relapse in the month prior to enrollment * Treatment with oral or parenteral steroids for any cause in the month prior to enrollment * Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders * Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment * Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast. * Positive serology for HIV, Hepatitis B or Hepatitis C * Any history of malignancy or exposure to radiation at any time prior to enrollment * Any contra-indication to lumbar puncture * Severe cognitive impairment that would interfere with the patient's ability 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

This study aims at expanding Umbilical Cord derived Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice and study its efficacy when compared to a Supervised Physical Therapy Program alone.

Papers

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Related trials

History

    1. Started

      Sept 2017

    2. Main results due

      Jan 2020

    3. Finished

      Feb 2020

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