Multiple sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention group: mesenchymal stem cells(MSCs) in a amountof 1×106 MSC/Kg with Rituximab (500-1000mg i.v).
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
17 Years to 45 Years
Inclusion criteria
Inclusion criteria: patients with SPMS Age between18–45 years Disease duration of 2 - 16 years Patients who are taking Rituximab drugs
Exclusion criteria
Exclusion criteria: Pregnant patients Patients with positive results from screening tests (HBV, HCV, HIV, HTLV) Patients with other systemic problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and side effects of PLMSCs transplantation in terms of pain. Timepoint: baseline, 1,3,6 and 9 months after PLMSCs injection. Method of measurement: self-reported of patients.;Safety and side effects of high dose PLMSCs transplantation in terms of hypersensitivity. Timepoint: baseline, 1,3,6 and 9 months after PLMSCs injection. Method of measurement: clinical observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of stem cell transplantation in terms of infection. Timepoint: baseline, 1,3 months after MSCs injection. Method of measurement: CBC, LP.;Severity of clinical scores. Timepoint: baseline, 1,3,6 and 9 months after MSCs transplantation. Method of measurement: clinical observation by neurologist.;Assessment of neurological function. Timepoint: baseline, 6 and 9 months after After MSCs transplantation. Method of measurement: Magnetic resonance imaging (MRI).;Assessment of Biomarkers concentrations in peripheral blood of patients. Timepoint: baseline,1,3, 6 months after SCs transplantation. Method of measurement: Flowcytometery. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmeneh Shokati
Tehran University of Medical Sciences
Outcome results
None listed