Disease: Multiple Sclerosis
Type of study: Interventional trial
Coordinating investigator: Christopher Elnan Kvistad
Study director: Lars Bø
Information for patients: on this page (Norwegian only).
Background: There is currently no effective treatment available to promote repair of damage to the central nervous system (CNS), caused by multiple sclerosis (MS), and thereby to reverse neurological disability. Mesenchymal stem cells (MSCs) have the potential to induce neuronal repair through multiple neurodegenerative mechanisms, including remyelination, immunomodulation and stimulation of endogenous cerebral stem cells. In this study, the group aims to investigate the regenerative potential of stem cell treatment with MSCs in MS and to increase the understanding of the underlying mechanisms of action.
The objective of this pilot project is to study whether intrathecal treatment with autologous bone marrow derived MSCs is feasible, safe and promotes neural repair in patients with progressive MS.
Design: This is a randomised placebo-controlled cross-over pilot trial comparing the efficacy and safety of autologous bone marrow derived MSCs (n=9) compared to placebo (n=9) in progressive multiple sclerosis patients.
The primary endpoint of the study is the difference in the change of composite score (CEP) of three neurophysiological measures (somatosensory evoked potentials (SEP), visual evoked potentials (VEP) and motor evoked potentials (MEP)) from baseline between MSC treatment versus placebo.
The study is performed as a collaboration between Haukeland University Hospital, the Tissue Engineering Group at the University of Bergen, the University Hospital in Ulm, Germany, and coordinating centres in all Norwegian health regions, including Akershus University Hospital (Lørenskog), St. Olav’s Hospital (Trondheim), and the University Hospital of North Norway (Tromsø).
Status: The first patient was included at Haukeland University Hospital in August 2021 and the study inclusion was completed in 2023. The final study visit will take place in first quarter of 2025.
Participating centres
Norway
- Haukeland University Hospital, Bergen
- Akershus University Hospital, Lørenskog
- Olav’s University Hospital, Trondheim
- University Hospital of North Norway, Tromsø
Germany
- University Hospital in Ulm
The Netherlands
- Amsterdam University Medical Centre
Funding
- KLINBEFORSK
- The Regional Health Authority of Western Norway
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- The University of Bergen
- Participating hospitals
- The Norwegian MS Society
- The Red Cross