Treatment for Multiple Sclerosis Using Stem Cell Transplantation
Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation (MS-ACT): A Long-term Prospective Observational Study in the Netherlands
Amsterdam UMC, location VUmc · NCT06567197
This study is testing the long-term effects of a stem cell treatment for people with active relapsing-remitting multiple sclerosis to see how it impacts their health over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc (other) |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT06567197 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term effects of autologous hematopoietic stem cell transplantation (aHSCT) in patients with highly active relapsing-remitting multiple sclerosis. Participants will undergo regular evaluations over five years, including clinical tests, questionnaires, MRI scans, and blood sampling to monitor disease activity, safety, and immune system changes. The study follows patients approved for aHSCT treatment in the Netherlands, adhering to specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are patients with highly active relapsing-remitting multiple sclerosis who meet the Dutch criteria for aHSCT treatment.
Not a fit: Patients with contraindications for aHSCT, severe comorbidities, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce disease activity and improve the quality of life for patients with relapsing-remitting multiple sclerosis.
How similar studies have performed: Previous studies have shown promising results with aHSCT in treating multiple sclerosis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam and 1 other locations
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
- St. Antonius Hospital — Nieuwegein, Netherlands (RECRUITING)
Study contacts
- Principal investigator: J. Killestein, MSc, PhD — Amsterdam UMC
- Study coordinator: Rick Heijnen, MSc
- Email: r.m.heijnen@amsterdamumc.nl
- Phone: +31627228507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Relapsing-Remitting