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

Highdose Chemotherapy and transplantation of 34+ selected stem cell for progressive systemic sclerosis Modification according to manifestation - AST-MOMA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002434-40-DE

Enrollment

Registered

2011-08-18

Start date

2012-03-23

Completion date

Unknown

Last updated

2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic sclerosis MedDRA version: 14.1 Level: LLT Classification code 10059040 Term: Autologous peripheral haematopoietic stem cell transplant System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: CD34 selected autologous hematopoietic cells Product Code: CD34+SC Pharmaceutical Form: Suspension for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: ? Age 50mmHg ? Kidney insiffiency with Clearance for creatinine 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To optimise the treatment for severe systemic sclerosis with high dose chemotherapy and autologous stem cell transplantation by adapting the procedure to the individual organ manifestation. ;Secondary Objective: Reduction of treatment related mortality;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Month 6, 12, 24, 30, 36	—

Secondary

Measure	Time frame
Secondary end point(s): Safety (treatment related mortality/toxicity) Progression free survival Frequency of cardiac manifestations Efficacy (mRSS; sHAQ, DLCO/IVC) ;Timepoint(s) of evaluation of this end point: Month 6, 12, 24, 30, 36	—

Countries

Germany

Contacts

Public ContactDepartment Internal Medicine II

University Hospital Tuebinegn

joerg.henes@med.uni-tuebingen.de004970712980681

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026