A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis
- Conditions
- Severe systemic sclerosis
- Registration Number
- JPRN-UMIN000028381
- Lead Sponsor
- Department of Clinical Immunology and Rheumatology/Infectious Disease, Kyushu University Graduate school of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Not provided
(1) severe organ dysfunction as following a) severe arrhythmia leading to permanent implantation of a pacemaker or implantable cardioverter defibrillator, refractory chronic heart failure, reduced left ventricular ejection fraction lower than 50% at echocardiogram or severe pulmonary hypertension (mPAP >=30 mmHg) b) severe lung dysfunction (PaO2 <60 mmHg under room air conditions, %FVC <50% or %DLOC <20%) c) severe renal dysfunction (eGFR <40 ml/min or serum Cr >=2 mg/dl) d) d) liver abnormality (baseline AST, ALT or total bilirubin levels are >3 times higher than upper limit of normal) (2) presence of malignancy except for complete remission (3) presence of active infection (4) positive for HBs-Ag, HCV-Ab, HIV-Ab or HTLV1-Ab test (5) cumulative dose of more than 10 g of cyclophosphamide (6) history of anaphylaxis or hypersensitivity to murine IgG or iron-dextran complex (7) pregnancy or lactation (8) judged by the investigator to be inappropriate for study participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method