Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands
Recruiting · NCT06567197 · Observational (researchers observe without assigning treatment) · Lead sponsor: Amsterdam UMC, location VUmc
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed.
- Amsterdam UMC - Amsterdam, Netherlands
- St. Antonius Hospital - Nieuwegein, Netherlands