EBMT ADWP Prospective Non Interventional Study : AutoHSCT in SSc Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autoimmune Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NISSC

Autologous HSCT

Intervention Type PROCEDURE

1st AHSCT

Interventions

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Autologous HSCT

1st AHSCT

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No