NCT06360861CompletedPhase 1
Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis
An Open-label, Non-randomized, Phase I Study of Allogeneic Placenta Derived Mesenchymal Stem Cells in Patients With Secondary-Progressive Multiple Sclerosis (SPMS),
Source: ClinicalTrials.gov · Last updated 11 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 17 Mar 2024
- Start date
- 23 Jul 2019
- Primary completion date
- 4 Mar 2024
- Lead sponsor
- Tehran University of Medical Sciences
- Diseases
- Multiple sclerosis
- NCT number
- NCT06360861
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 5
- From 23 Jul 2019 to the primary completion date, 4 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Using cytotoxic agents within 3 months prior to the study.
- Current treatment with an investigational therapy.
Other illness
- hepatitis B and C, human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) disease.
- history of malignancy .
- liver disorders .
- significant cardiac, renal or hepatic failure .
- Active or chronic infection.
Lab values
- Severe anemia (hemoglobin\< 8 mg/dl), coagulation disorders.
Other
- Pregnancy or breastfeeding.
- Life-threatening organ dysfunction.
- Unable to give written informed consent .
Who the study is looking for
- 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.
Criteria the registry did not label
- Criteria:
Age in the registry: 17 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tehran University of Medical Sciences,Tehran, Iran Coordinator of this site? Confirm its status | Tehran | Iran | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.