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| Name | Class |
|---|---|
| University of Bergen | OTHER |
| University Hospital Ulm | OTHER |
| University Hospital, Akershus | OTHER |
| University Hospital of North Norway |
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The primary objective of the study is to investigate neuroregenerative efficacy (proof of concept) of intrathecal treatment with autologous MSCs as measured by neurophysiological parameters in patients with progressive MS.
Secondary objectives are to assess neuroregenerative efficacy as measured by other neurophysiological parameters as well as clinical, opthalmological and MRI modalities, and to assess safety of the treatment procedure.
Prospective, interventional, randomized, placebo-controlled, cross-over study. Patients are randomized to either treatment arm A or B.
Patients in both treatment arms receive intrathecal autologous MSCs, arm A at baseline and arm B at six months.
All patients undergo bone marrow (BM) aspiration prior to baseline. Patients in treatment arm A receive intrathecal autologous MSCs whereas patients in treatment arm B receive placebo. The treatment is blinded for the patients. The BM aspirate from patients in treatment arm B is processed, cryopreserved and stored in a biobank.
At six months, all patients undergo a second BM aspiration. Patients in treatment arm A now receive placebo. The BM aspirate from patients in treatment arm A is processed, cryopreserved and stored in a biobank. Patients in treatment arm B receive intrathecal autologous MSCs. The treatment is blinded for the patients.
Primary outcome is assessed at six months and secondary outcomes are assessed at six, twelve and eighteen months post baseline. Investigator assessing outcomes are blinded to patient treatment allocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Crossover with MSCs at baseline and placebo at 6 months | Experimental | Receives mesenchymal stem cells at baseline and placebo at 6 months |
|
| Arm B - Crossover with placebo at baseline and MSCs at 6 months | Experimental | Receives placebo at baseline and mesenchymal stem cells at 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSCs | Other | Autologous bone-marrow derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurophysiological parameters - Combined evoked potentials | Somatosensoric evoked potentials (SEP) + visual evoked potentials (VEP) + motor evoked potentials (MEP), latency (ms) and amplitude (mV) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurophysiological parameters - Somatosensoric evoked potantials | SEP, latency (ms) and amplitude (mV) | 6 and 12 months |
| Neurophysiological parameters - Motor evoked potentials | MEP, latency (ms) and amplitude (mV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Elnan Kvistad, PhD | Haukeland University Hospital | Principal Investigator |
| Lars Bø, Prof | Haukeland University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus university hospital | Lørenskog | Akershus | Norway | |||
| University hospital of North Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42081777 | Derived | Kvistad CE, Krakenes T, Holmoy T, Eidem LE, Steffensen L, Wesnes K, Rojewski M, Eichele T, Wergeland S, Gavasso S, Barsnes H, Assmus J, Al-Sharabi N, Mohamed-Ahmed S, Vrenken H, Brouwer I, Mutsaerts HM, Tranfa M, Gjerde C, Ytterdal M, Rodahl E, Berven FS, Schrezenmeier H, Mustafa K, Bo L. Intrathecal Mesenchymal Stem Cells in Progressive Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial (SMART-MS). Neurology. 2026 May 26;106(10):e214915. doi: 10.1212/WNL.0000000000214915. Epub 2026 May 4. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| OTHER |
| St. Olavs Hospital | OTHER |
Prospective, randomized, placebo-controlled, cross-over study
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| Saline | Drug | Isotonic saline |
|
| 6 and 12 months |
| Neurophysiological parameters - Visual evoked potentials | VEP, latency (ms) and amplitude (mV) | 6 and 12 months |
| MRI-Lesion volumes | T1- and T2-weighted hyperintense lesion volume | 6 and 12 months |
| MR- Brain volumes | Brain volumes | 6 and 12 months |
| Expanded disability status scale | EDSS | 6, 12 and 18 months |
| Patient reported outcomes (PROs) | Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), European Quality of Life 5 dimensions (EQ-5D-5L), Multiple Sclerosis Impact Scale (MSIS) and Fatigue severity scale (FSS) | 6, 12 and 18 months |
| Nine-Hole-Peg Test (9-HPT) | Nine-Hole-Peg Test (9-HPT) | 6, 12 and 18 months |
| Timed 25 Foot Walk (T25FW) | Timed 25 Foot Walk (T25FW) | 6, 12 and 18 months |
| Visual function | Visual acuity, visual field, color vision and contrast sensitivity | 6, 12 and 18 months |
| Optical coherence tomography (OCT) | Retinal thickness | 6, 12 and 18 months |
| Rate and nature of adverse- and serious adverse events | Adverse events | 6, 12 and 18 months |
| Tromsø |
| Troms Og Finnmark |
| Norway |
| St.Olav university hospital | Trondheim | Trøndelag | Norway |
| Haukeland University Hospital | Bergen | Vestland | Norway |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |