Transplantation of stem cells for the treatment of svere systemic sclerosis with a protocol which is adapted to individual manifestatons of the disease

Phase 1

• Conditions: Systemic sclerosis; MedDRA version: 14.1Level: LLTClassification code 10059040Term: Autologous peripheral haematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-002434-40-DE
• Lead Sponsor: niversity Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-18
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

?Limited or diffuse cutaneous systemic sclerosis with organ manifestation (lung/heart or kidney)
?Progressive disease despite cyclophosphamide treatment
?Cyclophosphamide i.v.: at least 3 x 500-1000 mg/m² every 3-4 weeks or
?Oral Cyclophosphamide with at least 100mg/day for at least 2 months or
?or contraindications for a cyclophosphamide treatment
?Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Age < 18 years
?Pregnancy or unwillingsness to use contraception
?Concomittend severe disease
?Heart insuffiency with EF < 30% (echo)
?Pulmonary arterial hypertension with papSys > 50mmHg
?Kidney insiffiency with Clearance for creatinine < 30ml/min
?Severe limitation in lung function test
?IVC < 50%
?DLCO = 30%
?Bone marrow defect
?Leukopenia < 2.000/ul
?Thrombopenia < 100.000/ul
?Cyclophosphamide sum dose > 50g (relative)
?Chronic infection (Hepatitis B/C, HIV, salmonella, lues, tuberculosis (relative)
?Severe psychiatric disease
?Abuse of nicotine, alcohol or any illegal drugs
?Poor compliance

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified