Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Relapsing-Remitting. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation (MS-ACT): A Long-term Prospective Observational Study in the Netherlands
Overview
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.
Primary outcome measures
- Treatment efficacy [Time frame: 2 years]
Secondary outcome measures (12)
- Annual relapse rate [Time frame: 2 years]
- Time to first relapse [Time frame: 2 years]
- Confirmed disability progression (CDP) [Time frame: 2 years]
- Confirmed disability improvement (CDI) [Time frame: 2 years]
- Progression independent of relapse activity (PIRA) [Time frame: 2 years]
- Changes on the multiple sclerosis functional composite (MSFC) [Time frame: 2 years]
- Brain/spinal cord MRI [Time frame: 2 years]
- Optical coherence tomography (OCT) [Time frame: 2 years]
- Side-effects and toxicity [Time frame: 2 years]
- Multiple Sclerosis Impact Scale-29 (MSIS-29) [Time frame: 2 years]
- EuroQoL 5D (EQ-5D-5L) [Time frame: 2 years]
- Modified Fatigue Impact Scale (MFIS-5) [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS
Exclusion criteria
- 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
- Active infections such as but not limited to tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes simplex, varicella zoster, viral hepatitis, toxoplasmosis, HIV or syphilis.
- Active malignancy or history of malignancy with the exception of local basal cell carcinoma or carcinoma in situ of the cervix
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- Amsterdam UMC — Amsterdam
- St. Antonius Hospital — Nieuwegein
Identifiers
NCT: NCT06567197 · NL83783.018.23