NCT06567197Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 24 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- 25 Aug 2023
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Multiple sclerosis
- NCT number
- NCT06567197
What you commit to
- Study type: Observational
- Planned participants: 24
- From 25 Aug 2023 to the primary completion date, 1 Sept 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Severe clinical depression
Who the study is looking for
- All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.