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OpenTrials
Completed

NCT Number: NCT06360861

Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Mesenchymal Stem Cells Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Secondary-progressive Multiple Sclerosis

Age range

17 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tehran University of Medical Sciences,Tehran, Iran

Tehran, Iran

About this study

This open-label phase I study will be conducted in MS Clinic of Sina and Shariati Hospital of Tehran province .

In this study, diagnosis and management of MS patients will be performed based on McDonald's criteria and Iran's diagnostic and treatment protocols.

The patients will be received a single injection of PLMSCs through the intravenous cannula.

The proposed study will assess safety and short efficacy endpoints of PLMSCs administered to 5 patients with SPMS.

The primary objective of the trial is freedom from treatment associated adverse events at 1,3 and 6 months' post treatment. Secondary objective will be efficacy as assessed at baseline, at 1,3 and 6 months and will be based on the following: EDSS, cytokines, DTI, fMRI, cognitive & psychological evaluations, and flow cytometry for B cell markers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allogenic placenta derived mesenchymal stem cells

Biological

Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection.

Primary outcomes

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

    Time frame: Up to 6 months

    adverse events

Secondary outcomes

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

    Time frame: Up to 6 months

    Proportion of patients with clinical improvement in EDSS score compared to baseline. EDSS scores range from 0 = no disability to 10 = death due to MS and higher scores mean a worse outcome.

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

    Time frame: Up to 6 months

    The minimum score is 0 and maximum score is 60, and higher scores mean a better outcome.

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

    Time frame: Up to 6 months

    Assessment of cognitive function

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

    Time frame: Up to 6 months

    Assessment of brain connectivity

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

    Time frame: Up to 6 months

    Change from baseline in white matter integrity

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

    Time frame: Up to 6 months

    Change from baseline in processing and motor speed of patients and higher scores mean a better outcome.

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

    Time frame: Up to 6 months

    Change from baseline in verbal learning and memory deficits and higher scores mean a better outcome.

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

    Time frame: Up to 3 months

    Blood samples will be collected pre and post treatment for immediate or ulterior analysis.

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

    Time frame: Up to 3 months

    Blood samples will be collected pre and post treatment for immediate or ulterior analysis.

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

    Time frame: Up to 6 months

    Change from baseline in T2 lesion volume.

  11. Proportion of patients with change in brain volume on MRI.

    Time frame: Up to 6 months

    Change from baseline in brain volume

  12. Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised .

    Time frame: Up to 6 months

    Change from baseline in visuospatial learning

  13. Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test .

    Time frame: Up to 6 months

    Change from baseline in visuospatial ability

  14. Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests.

    Time frame: Up to 6 months

    Change from baseline in executive functions

  15. Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test .

    Time frame: Up to 6 months

    Change from baseline in measuring verbal fluency

  16. Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised .

    Time frame: Up to 6 months

    Symptom Checklist-90(SCL-90) is a collection of nine subscales (with 90 items) for evaluation of Somatization, Obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism in the past week. Each item has a 5-point Likert scale and scoring from 0 to 4. SCL-90 Global Severity was calculated by dividing the sum of all subscales scores by 9.

  17. Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale .

    Time frame: Up to 6 months

    Fatigue Severity Scale(FSS )is a scale with 9 items, which assesses the fatigue severity in the past 2 weeks. Each item has a score from 1 to 7 and total score will be from 9 to 63. Higher FSS score indicates higher fatigue severity.

  18. Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test.

    Time frame: Up to 6 months

    Change from baseline in visuospatial ability

  19. Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test.

    Time frame: Up to 6 months

    Change from baseline in visuospatial ability

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: MS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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