Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cel

An Open-label, Non-randomized, Phase I Study of Allogeneic Placenta Derived Mesenchymal Stem Cells in Patients With Secondary-Progressive Multiple Sclerosis (SPMS),

CompletedPhase 1Progressive MSNCT06360861

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

  • Allogenic placenta derived mesenchymal stem cells

What it measured

Main measures

  • Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability].

    Up to 6 months

    Safety

Other measures (19)

  • Number of participants with a change in disability as measured by Expanded Disability Status Scale .

    Up to 6 months

    Disability progression

  • Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test .

    Up to 6 months

    Thinking and memory

  • Number of participants with a change in cognitive performance as measured by Persian version of minimal assessment of cognitive function in MS battery.

    Up to 6 months

    Thinking and memory

  • Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging .

    Up to 6 months

    MRI lesionsNerve conduction tests

  • Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging .

    Up to 6 months

    MRI lesions

  • Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test .

    Up to 6 months

    Thinking and memory

  • Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition .

    Up to 6 months

    Thinking and memory

  • Proportion of patients with change in CD20 / CD19 B cells surface markers

    Up to 3 months

    Immune response

  • Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines.

    Up to 3 months

    Immune response

  • Proportion of patients with change in T2 lesion volume on brain MRI.

    Up to 6 months

    MRI lesions

Who could take part

Progressive MS · 17 to 45

Show the full criteria

Inclusion criteria

Criteria: Inclusion Criteria: * Age between 17-45 years Patients with SPMS . * Must be able to Sign informed consent . * Currently taking Rituximab. * Disease duration of more than 2 and less than 16 years.

Exclusion criteria

* Pregnancy or breastfeeding. * hepatitis B and C, human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) disease. * Using cytotoxic agents within 3 months prior to the study. * Severe anemia (hemoglobin\< 8 mg/dl), coagulation disorders. * history of malignancy . * liver disorders . * significant cardiac, renal or hepatic failure . * Active or chronic infection. * Life-threatening organ dysfunction. * Unable to give written informed consent . * Current treatment with an investigational therapy.

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 and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells (PLMSCs) in patients with secondary progressive Multiple Sclerosis (SPMS) disease. Monitoring will be encompassed baseline assessments and follow-ups over subsequent months, evaluating clinical signs, Expanded Disability Status Scale (EDSS), cytokines, diffusion tensor imaging (DTI), functional MRI (fMRI), cognitive \& psychological evaluations, and flow cytometry for B cell markers.

Papers

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Related trials

History

    1. Started

      Jul 2019

    2. Main results due

      Mar 2024

    3. Finished

      Mar 2024

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