Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAmsterdam UMC, location VUmc
About this trial
The goal of this observational study is to study the long-term effects of autologous hematopoietic stem cell transplantation (aHSCT) in people with highly active relapsing-remitting multiple sclerosis. The study will evaluate the following items:
1. Disease activity 2. Safety and tolerability of aHSCT 3. Changes in the immune system
Participants will be subjected to frequent visits for five years after treatment with aHSCT. During these visits, clinical testing, evaluation by questionnaires, MRI scans and blood sampling will be performed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS
Disqualifiers
Contra-indications for treatment with aHSCT such as known hypersensitivity to the medication used for aHSCT
Clinically relevant comorbidities preventing safe use of medication used for aHSCT
Severe clinical depression
Active addiction to drugs or alcohol
Trial population
Patients with highly active relapsing-remitting multiple sclerosis are eligible for treatment with aHSCT in the Netherlands if they meet the criteria as defined by the Dutch National Health Care Institute.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Treatment efficacy
The proportion of patients with ne evidence of disease activity-3 (NEDA-3) as defined by: no clinical relapse, no disability progression, no radiological disease activity.
Time frame
2 yearsSecondary outcomes
1
Annual relapse rate
Time frame
2 years2
Time to first relapse
Time frame
2 years3
Confirmed disability progression (CDP)
Measured by the Expanded Disability Status Scale (EDSS) CDP-EDSS is defined as an increase of one point in the EDSS score from baseline to month 24.
Time frame
2 years4
Confirmed disability improvement (CDI)
Measured by the Expanded Disability Status Scale (EDSS) CDI-EDSS is defined as a decrease of one point in the EDSS score from baseline to month 24, with an absence of relapse at the point of assessment.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Amsterdam UMC, location VUmc
Lead sponsor
St. Antonius Hospital
Collaborator
Source ClinicalTrials.gov