The effect of MSCs transplantation in the treatment of SPMS
Phase 1
- Conditions
- Multiple sclerosis.Multiple sclerosis
- Registration Number
- IRCT20210614051576N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
patients with SPMS
Age between18–45 years
Disease duration of 2 - 16 years
Patients who are taking Rituximab drugs
Exclusion Criteria
Pregnant patients
Patients with positive results from screening tests (HBV, HCV, HIV, HTLV)
Patients with other systemic problems.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.