EBMT ADWP Prospective Non Interventional Study : AutoHSCT in SSc Patients (NISSC)

European Society for Blood and Marrow Transplantation

Status: Completed

Conditions: Autoimmune Diseases

Treatments: Procedure: Autologous HSCT

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02516124

NCT02516124

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness of Autologous Hematopoietic Stem Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis (SSc) as currently performed by different study protocols used across Europe in various EBMT centres through the careful recording and analysis of routinely collected clinical and biological data.

Full description

Different protocols are used in the different centres, it is not yet clear which approach will be the most efficient and the safest. Every centre will follow its own local protocol for AHSCT which usually refers to the recent update of the EBMT Guidelines for HSCT in autoimmune disease. Patient selection for AHSCT treatment technique with regard to the risk/benefit balance has to be carefully addressed by standard patient pretransplant evaluation, whereas treatment local regimen, follow-ups evaluation, supportive medication and prophylaxis will be recorded and analysed.

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Autologous HSCT
• Age between 18 and 65 years at time of transplant.
• Established diagnosis of progressive systemic sclerosis according to ARA-criteria

Exclusion criteria

• Pregnancy or inadequate contraception
• Severe concomitant disease
• Reduced lung function
• Previously damaged bone marrow
• Uncontrolled severe infection
• Severe concomitant psychiatric illness

Trial design

82 participants in 1 patient group

NISSC

Description:

Autologous HSCT

Treatment:

Procedure: Autologous HSCT