Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multipl… (NCT06360861) | Clinical Trial Compass
CompletedPhase 1
Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Iran5 participantsStarted 2019-07-23
Plain-language 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.
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.
Who can participate
Age range
17 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability].