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Multiple SclerosisPhase 1MSNCT06360861

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

A Phase 1 study testing Allogenic placenta derived mesenchymal stem cells in people with Multiple Sclerosis and Secondary-Progressive Multiple Sclerosis, run by Tehran University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 17 to 45 years
What is being tested?
Allogenic placenta derived mesenchymal stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteIran
Study dates
23 Jul 2019to 6 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 .
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  • 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.

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Tehran University of Medical Sciences,Tehran, Iran

    Tehran

Other trials in Iran

About this study

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

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.

Read the detailed description

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.

Being tested
Allogenic placenta derived mesenchymal stem cells
Keywords
Mesenchymal Stem cells, Multiple Sclerosis, Placenta derived Mesenchymal Stem Cells, Stem Cell therapy, Neuroimmunology, Autoimmune Disease
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogenic placenta derived mesenchymal stem cellsBiological

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

Study groups in NCT06360861
Study groupRoleWhat they receive
Placenta derived mesenchymal cellsExperimentalAllogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection
Receives: Biological: Allogenic placenta derived mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    adverse events

    Measured: Up to 6 months

Secondary outcomes (19)

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

    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.

    Measured: Up to 6 months

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

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

    Measured: Up to 6 months

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

    Assessment of cognitive function

    Measured: Up to 6 months

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

    Assessment of brain connectivity

    Measured: Up to 6 months

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

    Change from baseline in white matter integrity

    Measured: Up to 6 months

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

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

    Measured: Up to 6 months

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

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

    Measured: Up to 6 months

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

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

    Measured: Up to 3 months

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

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

    Measured: Up to 3 months

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

    Change from baseline in T2 lesion volume.

    Measured: Up to 6 months

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

    Change from baseline in brain volume

    Measured: Up to 6 months

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

    Change from baseline in visuospatial learning

    Measured: Up to 6 months

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

    Change from baseline in visuospatial ability

    Measured: Up to 6 months

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

    Change from baseline in executive functions

    Measured: Up to 6 months

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

    Change from baseline in measuring verbal fluency

    Measured: Up to 6 months

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

    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.

    Measured: Up to 6 months

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

    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.

    Measured: Up to 6 months

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

    Change from baseline in visuospatial ability

    Measured: Up to 6 months

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

    Change from baseline in visuospatial ability

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start23 Jul 2019
  3. Primary completion4 Mar 2024
  4. Study completion6 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label phase 1, single-center, pre-post comparison study
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06360861
Sponsor's protocol ID
1400-1-233-51589
Other IDs
IR.TUMS.MEDICINE.REC.1400.197
Acronym
MS
Status last verified
Mar 2024
First submitted
17 Mar 2024
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shokati A, Naser Moghadasi A, Nikbakht M, Sahraian MA, Mousavi SA, Ai J. A focus on allogeneic mesenchymal stromal cells as a versatile therapeutic tool for treating multiple sclerosis. Stem Cell Res Ther. 2021 Jul 13;12(1):400. doi: 10.1186/s13287-021-02477-5.

    PubMed 34256857

  • Ebrahimi-Barough S, Ai J, Payab M, Alavi-Moghadam S, Shokati A, Aghayan HR, Larijani B, Arjmand B. Standard Operating Procedure for the Good Manufacturing Practice-Compliant Production of Human Endometrial Stem Cells for Multiple Sclerosis. Methods Mol Biol. 2021;2286:199-212. doi: 10.1007/7651_2020_281.

    PubMed 32504294

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Allogenic placenta derived mesenchymal stem cells in people with Multiple Sclerosis and Secondary-Progressive Multiple Sclerosis, run by Tehran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability]. (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06360861, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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