Multiple Sclerosis. Demyelinating diseases of the central nervous system, multiple sclerosis
Conditions
Interventions
Intervention 1: Intervention group: endometrial Stem Cells in a amount of 5×106 MSC/Kg with Rituximab (500-1000mg i.v). Intervention 2: Control group: Rituximab (500-1000mg i.v) with placebo.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1)Women with SPMS who did not respond to their disease-modifying therapies . (2) Age between 18–45 years (3) EDSS less than 5.5 (4) Disease duration of 2 - 15 years.. (5) Women with at least one delivery (6) Women who are taking Rituximab drugs
Exclusion criteria
Exclusion criteria: Women under the age of 18 and over 45 years Pregnant patients Patients with positive results from screening tests for hepatitis B and C, human immunode?ciency virus (HIV), and human T-cell lymphotropic virus (HTLV) were also excluded from the study. Patients who had used cytotoxic agents or hormonal therapy within 3 months prior to the study . Patients with endometriosis and other uterine problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and side effects of hEnSCs transplantation in terms of pain. Timepoint: baseline, 1,3,6 and 9 months after hEnSCs injection. Method of measurement: self-reported of patients.;Safety and side effects of high dose hEnSCs transplantation in terms of hypersensivity. Timepoint: baseline, 1,3,6 and 9 months after hEnSCs injection. Method of measurement: clinical observation.;Safety of stem cell transplantation in terms of infection. Timepoint: baseline, 1,3,6 and 9 months after AT-MSCs injection. Method of measurement: CBC, LP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of clinical scores. Timepoint: baseline, 1,3,6 and 9 months after hEnSCs transplantation. Method of measurement: clinical observation by neurologist.;Assessment of neurological function. Timepoint: baseline, 1,3,6 and 9 months after After hEnSCs transplantation. Method of measurement: Magnetic resonance imaging (MRI).;Assessment of B cell markers CD19+CD20 percentage and MMP9 in peripheral blood of patients. Timepoint: baseline,1,3, 6 and 9 months after SCs transplantation. Method of measurement: Flowcytometery , eliza. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmeneh Shokati
Tehran University of Medical Sciences
Outcome results
None listed