Status:
COMPLETED
Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Scleroderma
Cardiac Involvement
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Autologous stem cell therapy has been shown to be effective in patients with systemic sclerosis. Nevertheless treatment is associated with treatment related mortality and patients die during follow up...
Eligibility Criteria
Inclusion
- Diagnosis of progressive systemic sclerosis \<7 years
- Progressive course despite cyclophosphamide pretreatment
- Cyclophosphamide i.v.: at least 3 x with 500-1000 mg/m² every 3-4 weeks or
- Cyclophosphamide p.o. with at least 100mg/day for at least 2 months or
- Contraindication to treatment with cyclophosphamide
- Progress defined as at least one of the following criteria:
- Increase in the mRSS
- Worsening of the lung function
- Increase in fibrosis/alveolitis in thorax CT
- Worsening kidney function through manifestation of systemic sclerosis
- Limited or diffuse cutaneous progressive form of Ssc with organ manifestation in the lungs/heart or kidneys
Exclusion
- Age \<18 years
- Pregnancy or inadequate contraception
- Severe heart failure with ejection fraction (EF) \< 30% in echo
- Pulmonary arterial hypertension with systolic pulmonary arterial pressure (PAPsys) \>50mm Hg
- Kidney insufficiency: creatinine clearance \<30 ml/min
- Reduced lung function
- Inspiratory vital capacity (IVC) \< 50% of normal
- Carbon monoxide (CO)-Diffusion capacity SB \< 40%
- Previously damaged bone marrow
- Leukopenia \< 2,000/µl
- Thrombopenia \< 100,000/µl
- Previous myelotoxic treatment:
- Cyclophosphamide \> 50g cumulative (relative)
- Infection (Hepatitis B/C, HIV, Salmonella carrier, syphilis, relative: history of tuberculosis)
- Severe concomitant psychiatric illness (depression, psychosis)
- Substance dependence
- Continued nicotine abuse
- Continued alcohol abuse
- Continued drug abuse
- Consent not given
- Poor compliance
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01895244
Start Date
September 1 2012
End Date
June 1 2024
Last Update
July 29 2024
Active Locations (1)
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1
University Hospital Tuebingen; Department of oncology, hematology, rheumatology, immunology and pulmology
Tübingen, Germany, 72076