RecruitingNCT06567197

Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands

Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation (MS-ACT): A Long-term Prospective Observational Study in the Netherlands

Sponsor

Amsterdam UMC, location VUmc

Enrollment

24 participants

Start Date

Aug 25, 2023

Study Type

OBSERVATIONAL

Conditions

Multiple Sclerosis, Relapsing-Remitting

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS

Exclusion Criteria6

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