The effect of fat-derived stem cells in treatment of multiple sclerosis
Phase 1
Recruiting
- Conditions
- multiple sclerosis.Demyelinating diseases of the central nervous system, multiple sclerosisG35-G37
- Registration Number
- IRCT20091127002778N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 10
Inclusion Criteria
Patients with MS according to McDonald criteria
Secondary Progressive MS according to neurologist comment and standard critria
Expanded Disability Status Scale (EDDS) score 3 -6.5
Failure to response to the available disease modifying treatments
age under 50 years
female
Exclusion Criteria
Having relapses within the month prior to trial
Using steroid drugs within the month prior to trial
History of malignancy
Acute or chronic infection
Immunodeficiency
Pregnancy
Lactating woman
Cardiac, renal or hepatic failure
Positive serology for HIV, Hepatitis B, Hepatitis C
Incapability for a biopsy of at least 50 grams of fat tissue
Treatment with any disease modifying treatment during the trial
Patients unable to give written informed consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and side effects of high dose Adipose-Tissue MSCs transplantation in terms of pain. Timepoint: baseline, 1,3,6 and 9 months after AT-MSCs injection. Method of measurement: self-reported of patients.;Safety and side effects of high dose Adipose-Tissue MSCs transplantation in terms of hypersensivity. Timepoint: baseline, 1,3,6 and 9 months after AT-MSCs 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, 6 and 9 months after Adipose-Tissue MSCs transplantation. Method of measurement: clinical observation by neurologist.;Assessment of neurological function. Timepoint: baseline, 6 and 9 months after After-Tissue MSCs transplantation. Method of measurement: Magnetic resonance imaging (MRI).;Assessment of Tregulatory CD4+CD25+FOXP3+ percentage and lack of CD127 in peripheral blood of patients. Timepoint: baseline,1,3, 6 and 9 months after AT-MSCs transplantation. Method of measurement: Flowcytometery.