Refractory systemic sclerosis
Conditions
Interventions
Case series:Intravenous infusion of mesenchymal stem cells
Sponsors
Department of Rheumatology and immunology, Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-60 years old; 2. According to the American College of Rheumatology diagnostic criteria in 1980, it is consistent with ACR scleroderma. Standard is as follows: (1) near-end SSc (MCP/MTP near-end); (2) Abdominal depressed scar; (3) Finger hardening; (4) Pulmonary fibrosis (CXR: HRCT); Must meet two items of (1) or (2), (3), (4) 3. Refractory scleroderma, including life-threatening organ damage (heart, lung, kidney) and contraindications or resistance to immunosuppressants (cyclophosphamide, methotrexate, mycophenolate mofetil) 6 months or intensive treatment) or systemic scleroderma fibrosis involving the lungs but not requiring lung transplantation. These severe types and severe systemic scleroderma were followed up for at least 6 months, and high-dose cyclophosphamide was administered intravenously before oral administration, methotrexate, and mycophenolate immunosuppressive therapy. Months, there is rapid progressive skin damage (Rodnan score > 15 points) and one or more major visceral lesions, defined as follows: 1) Respiratory diseases: DLC0 40 mmHg but <70 mmHg, Need to rule out the cause not related to scleroderma. 4. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Women who have not used contraception during pregnancy or during the trial; 2. Respiratory diseases: 1) DLCO 6.7 kPa (50 mmHg); 3. Kidney disease; 1) Creatinine clearance 70 mmHg); 4) Chronic atrial fibrillation requires oral anticoagulant therapy; 5) refractory ventricular arrhythmia; 6) Echocardiography to assess a large number of pericardial effusions and hemodynamic abnormalities; 5. Liver disease: 1) Liver damage, transaminase and bilirubin are higher than 3 times normal; 2) Active hepatitis B or hepatitis C; 6. Mental illness, including drug use and alcohol abuse; 7. Active tumors or concomitant spinal dysplasia, precancerous lesions; 8. Bone marrow failure, neutropenia <0.5 x 10^9 / L, thrombocytopenia <50 x 10^9 / L, anemia <8 g / dL, CD4 lymphopenia <200 x 10^6 / L; 9. Refractory hypertension; 10. Refractory acute or chronic infection, serological HIV-Ab positive; 11. Prolonged exposure to bleomycin, toxic oil, vinyl chloride, trichloroethylene or silica; 12. Eosinophilia, rheumatic polymyalgia, fasciitis; 13. Poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved Rodnan skin thickness score;DLCO;Health Assessment Questionnaire Disability Index Scale (HAQ-DI);CT score of interstitial lung disease;Pulmonary artery pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dosage of glucocorticoid;Visual analogue scale (VAS score);IL-6;TGF-ß;TNF-a; | — |
Countries
China
Contacts
Public ContactSonglou Yin
Outcome results
None listed