Tracks long-term effects of stem cell transplant in relapsing multiple sclerosis
Follows adults with highly active relapsing multiple sclerosis after stem cell transplantation.
Plain-language title generated from the registry record
Registry title: Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands
Key facts
- Where
- Amsterdam and Nieuwegein, NetherlandsSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06567197, who can take part
Where in Netherlands
- Amsterdam UMCAmsterdam, NetherlandsTaking people
- St. Antonius HospitalNieuwegein, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC, location VUmc
- Trial code
- NCT06567197
- Record updated
- 22 August 2024
- Original description
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:Read full original descriptionShow less
Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation (MS-ACT): A Long-term Prospective Observational Study in the Netherlands
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.
Inclusion: All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS.
Exclusion: 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; 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; Severe clinical depression.