Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
NCT05359653
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
San Francisco, California, United States
View Trial DetailsNCT Number: NCT06567197
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Amsterdam UMC, Amsterdam, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
The proportion of patients with ne evidence of disease activity-3 (NEDA-3) as defined by: no clinical relapse, no disability progression, no radiological disease activity.
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Measured by the Expanded Disability Status Scale (EDSS) CDP-EDSS is defined as an increase of one point in the EDSS score from baseline to month 24.
Time frame: 2 years
Measured by the Expanded Disability Status Scale (EDSS) CDI-EDSS is defined as a decrease of one point in the EDSS score from baseline to month 24, with an absence of relapse at the point of assessment.
Time frame: 2 years
Defined as an episode of CDP without relapse during the 90 days before EDSS increase and during the 6-month period between the EDSS increase and the confirmation of disability progression.
Time frame: 2 years
MSFC consists of the timed 25-foot walk test, 9-hole peg test and standard digit modalities test (SDMT)
Time frame: 2 years
Presence and number of contrast-enhancing lesions at baseline and the development of new or enlarging lesions between baseline and follow-up will be assessed.
Time frame: 2 years
Developments of optic neuritis and longitudinal changes of the retinal nerve fiber layer will be assessed.
Time frame: 2 years
Frequency and type of (serious) adverse events such as infections, secondary auto-immunity, fertility problems, clinical relevant changes on physical examination and use of concomitant medications will be assessed
Time frame: 2 years
Patient reported outcome measures about the impact of MS on daily life
Time frame: 2 years
Patient reported outcome measures about quality of life
Time frame: 2 years
Patient reported outcome measures about fatigue
Time frame: 2 years
Patient reported outcome measures about anxiety and depression
Time frame: 2 years
Patient reported outcome measures about medical consumption
Time frame: 2 years
Patient reported outcome measures about productivity
Time frame: 2 years
Patient reported outcome measures about medication
Time frame: 2 years
Serum NfL and GFAP over time
Time frame: 2 years
Olink discover panel
Time frame: 2 years
Characterization of innate and adaptive immune subsets with mass spectrometry imaging
Time frame: 2 years
Immune gene profiling for gene signatures predictive for response to aHSCT
Contact information is provided by the study sponsor or research team.
Amsterdam UMC, location VUmc
Other
Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation (MS-ACT): A Long-term Prospective Observational Study in the Netherlands
Acronym: MS-ACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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