Status:
UNKNOWN
Observational Study in Multiple Sclerosis Patients Treated With Autologous Hematopoietic Stem Cell Transplantation
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
Observational prospective , multi-center study Primary objective : To gain further homogenous evidence for clinical efficacy of aHSCT in patients undergoing aHSCT for MS as primary indication. Secon...
Detailed Description
Currently, a number of new prospective comparative trials have either started or are in preparation, and the EBMT guidelines recommend treatment on a clinical trial, where available. However, some MS ...
Eligibility Criteria
Inclusion
- Diagnosis of MS according to McDonald's criteria
- Availability of a detailed clinical history about MS, including progression of disability and relapse rate in the previous 2 years, treatments administered before aHSCT, and categorization of the sub-types of MS according to current EBMT guidelines
- Highly active relapsing remitting MS failing DMTs
- Progressive MS with active inflammatory component. In accordance with the EBMT guidelines, this category includes both secondary and primary progressive MS with active inflammatory component.
- Aggressive (malignant) MS not previously treated with a full course of DMT
- Patients aged 18 or over at time of first aHSCT
- Signed informed consent
Exclusion
- Lack of one of the above criteria
- Progressive MS without active inflammatory component, as this indication is assigned 'GNR' according to EBMT guidelines, irrespective of whether it is secondary or primary progressive.
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient be able to return for the scheduled follow-up visits.
- Patients with cognitive impairments, who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are considered part of routine patient care.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04674280
Start Date
January 1 2021
End Date
January 1 2025
Last Update
December 21 2020
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