multiple sclerosis. Demyelinating diseases of the central nervous system, multiple sclerosis
Conditions
Interventions
intervention:Adipose-Tissue Mesenchymal Stem Cells in a amount of 5×106 MSC/Kg, each dosage include 2.5×106 MSC/Kg into MS patients, 2 dosage during 2 injection space 7 days apart.
Treatment - Drugs
intervention:Adipose-Tissue Mesenchymal Stem Cells in a amount of 5×106 MSC/Kg, each dosage include 2.5×106 MSC/Kg into MS patients, 2 dosage during 2 injection space 7 days apart
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
No minimum to 50 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahmoud Mahmoudi
Mashhad University of Medical Sciences
Outcome results
None listed