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

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

Plain Language Summary

Simplified for easier understanding

This study is following patients with relapsing-remitting multiple sclerosis (RRMS) — a form of MS characterized by episodes of worsening followed by partial recovery — who have been approved and are receiving autologous hematopoietic stem cell transplantation (aHSCT) in the Netherlands. This procedure uses the patient's own immune cells to reset the immune system. The study compares these patients' outcomes to those receiving standard MS medications. **You may be eligible if...** - You have relapsing-remitting multiple sclerosis - You have been approved to receive autologous stem cell transplantation (aHSCT) according to Dutch national criteria **You may NOT be eligible if...** - You have contraindications to the medications used in aHSCT - You have serious comorbid conditions that make the transplant unsafe - You have severe clinical depression - You have active addiction to drugs or alcohol - You have active infections including tuberculosis, hepatitis, HIV, cytomegalovirus, herpes, or others - You have an active or prior malignancy (other than local basal cell skin cancer or cervical carcinoma in situ) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Amsterdam UMC

Amsterdam, Netherlands

St. Antonius Hospital

Nieuwegein, Netherlands

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NCT06567197


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