The effect of hEnSCs transplantation in the treatment of SPMS

Phase 1

Recruiting

Conditions: Multiple Sclerosis.
Demyelinating diseases of the central nervous system, multiple sclerosis
G35-G37

Registration Number: IRCT20190711044175N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 10

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.