systemic sclerosis.
Conditions
Interventions
Intervention group: patients with severe systemic sclerosis according to diagnostic criteria. This group will receive about 10^6 cells/Kg Good manufacturing practices (GMP)-grade mesenchymal stem cell
Sponsors
Modiriat Atiyeh Bahman Company
Motamed Cancer Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Having severe systemic sclerosis according to the diagnostic criteria of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) The modified Rodnan skin score (mRSS) >15 without any restrictions on the duration of the disease Involvement of at least one major organ that is exclusively caused by systemic sclerosis; including one or more of the following: proven lung involvement with impaired diffusion capacity for carbon monoxide (DLCO) or predicted FVC drop below 80% or evidence of interstitial lung disease in chest X-ray and/or high-resolution imaging computed tomography (HRCT) scan cardiac involvement including: edema or inflammation in heart MRI, mild to severe pericardial effusion, congestive heart failure, atrial or ventricular arrhythmias including recurrent atrial fibrillation or flutter, recurrent atrial paroxysmal tachycardia, conduction abnormalities (2nd or 3rd degree atrioventricular block) Inadequate response to treatment according to the doctor's or patient's opinion, or the observation of more than three months of treatment complications, which are often caused by the following drugs: methotrexate 25 mg subcutaneous (or as tolerated) per week mycophenolate mofetil 2-3 gm/d (or as tolerated)
Exclusion criteria
Exclusion criteria: Pregnancy or unwillingness to use appropriate birth control methods Threatening end organ damage includes; Pulmonary failure, Heart failure in echocardiography, Pulmonary hypertension Simultaneously suffering from neoplasm or myelodysplasia Uncontrolled blood pressure Uncontrolled acute or chronic infection or high probability of viral infections Significant malnutrition with body mass index (BMI) < 18 kg/m2 Severe mental disorder Bone marrow failure Not accompanying the patient Simultaneous participation of the patient in other researches or researches that are accompanied by giving medicine Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment based on the rate of adverse events (grade 3 to 5) related to cell injection. Timepoint: up to 7days after injection. Method of measurement: Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Medsger Disease Severity Scale (DSS). Timepoint: between 0, 3, 6, 9 and 12 months. Method of measurement: The patients follow up. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Salimian
Iranian academic center for education culture and research
Outcome results
None listed