Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT03444805
Eligibility Criteria:
Inclusion Criteria:
1. \- Autologous HSCT
2. \- Age above 18 years at time of transplant.
3. -. Established diagnosis of progressive SSc according to 2013 ACR/EULAR classification criteria
Exclusion Criteria:
1. Pregnancy or inadequate contraception
2. Severe concomitant disease
3. Reduced lung, cardiac or renal function
a. .Reduced lung function with FVC \< 50% or DLCO \< 30% (of predicted values) b; .Pulmonary arterial hypertension with baseline (resting) PASP \> 40 mmHg or mPAP \> 25 mmHg or a PASP \> 45 mmHg or mPAP \> 30 mmHg after fluid challenge or Pulmonary vascular resistance \> 3 Wood units on RHC c. Severe heart failure with Ejection Fraction \< 45% by cardiac echocardiography d. D-sign of septal bounce on cardiac MRI e. Unrevascularized severe coronary artery disease f. Untreated severe arrhythmia g. Cardiac tamponade h. Constrictive pericarditis i. Kidney insufficiency: creatinine clearance \<30ml/min Previously damaged bone marrow
1. Leukopenia \< 2.0 x 109/L (total white cell count)
2. Thrombocytopenia \< 100 x 109/L
4. Uncontrolled severe or chronic infection (Hepatitis B/C, HIV, Salmonella carrier, syphilis, tuberculosis)
5. Severe concomitant psychiatric illness (depression, psychosis)
6. Concurrent neoplasms or myelodysplasia in the past 5 years
7. Smoking (current)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03444805
Study Brief:
Protocol Section:
NCT03444805