Multiple Sclerosis Clinical Trial
— SMART-MSOfficial title:
Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis
Verified date | September 2023 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 18 |
Est. completion date | January 4, 2025 |
Est. primary completion date | October 4, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: 1. Age =18 to =55, both genders 2. Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS 3. An EDSS score of 4 to 7 4. Disease duration 2 - 15 years 5. Signed, written informed consent Exclusion Criteria: 1. Any illness or prior/ongoing treatment that in the opinion of the investigators would jeopardize the ability of the patient to tolerate autologous stem cell treatment 2. Any ongoing infection, including Tbc, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV or syphilis infections, as well as heaptitis B surface antigen positivity and/or hepatitis C PCR positivity 3. Current immunomodulatory/immunosuppressive treatment 4. Immunomodulatory/immunosuppressive treatment within 6 months prior to inclusion. This includes, but is not restricted to treatment with natalizumab, fingolimod, dimetylfumurat, glatiramer acetate, interferon beta medications, teriflunomide, and siponimod. 5. Treatment with kladribin, ocrelizumab, rituximab, and alemtuzumab within 12 months prior to inclusion 6. Treatment with hematopoietic stem cell therapy within 12 months prior to inclusion 7. Treatment with glucocorticoids or ACTH within three months prior to start of inclusion 8. Having experienced an MS relapse within 2 years prior to study inclusion 9. Current treatment with fampridin 10. History of malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year 11. Severely limited life expectancy by another co-morbid illness 12. History of previous diagnosis of myelodysplasia or previous hematologic disease (including lymphoproliferative disease, bone marrow insufficiency or previous lymphoid irradiation) or current clinically relevant abnormalities of white blood cell counts 13. Immunocompromised patients 14. Estimated glomerular filtration rate <60 ml/min/1.73 m2 or known renal failure 15. Bleeding or clotting diathesis or the use of antithrombotic or anticoagulative treatment 16. Platelet (thrombocyte) count <100 x 10*9/L 17. Participation in another experimental clinical study within the preceding 12 months 18. Contraindications to MRI 19. Prior or current major depression 20. Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol. 21. Pregnancy or risk of pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study), breastfeeding or lactation 22. History of autologous/allogenic bone marrow transplantation or peripheral blood cell transplant 23. Known hypersensitivity against paracetamol, codein or xylocain 24. Diagnosis or strong suspicion of polyneuropathy 25. Prior or current alcohol or drug dependencies 26. Inability to give informed consent |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen | Vestland |
Norway | Akershus university hospital | Lørenskog | Viken |
Norway | University hospital of North Norway | Tromsø | Troms Og Finnmark |
Norway | St.Olav university hospital | Trondheim | Trøndelag |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | St. Olavs Hospital, University Hospital of North Norway, University Hospital Ulm, University Hospital, Akershus, University of Bergen |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurophysiological parameters - Combined evoked potentials | Somatosensoric evoked potentials (SEP) + visual evoked potentials (VEP) + motor evoked potentials (MEP), latency (ms) and amplitude (mV) | 6 months | |
Secondary | Neurophysiological parameters - Somatosensoric evoked potantials | SEP, latency (ms) and amplitude (mV) | 6 and 12 months | |
Secondary | Neurophysiological parameters - Motor evoked potentials | MEP, latency (ms) and amplitude (mV) | 6 and 12 months | |
Secondary | Neurophysiological parameters - Visual evoked potentials | VEP, latency (ms) and amplitude (mV) | 6 and 12 months | |
Secondary | MRI-Lesion volumes | T1- and T2-weighted hyperintense lesion volume | 6 and 12 months | |
Secondary | MR- Brain volumes | Brain volumes | 6 and 12 months | |
Secondary | Expanded disability status scale | EDSS | 6, 12 and 18 months | |
Secondary | 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 | |
Secondary | Nine-Hole-Peg Test (9-HPT) | Nine-Hole-Peg Test (9-HPT) | 6, 12 and 18 months | |
Secondary | Timed 25 Foot Walk (T25FW) | Timed 25 Foot Walk (T25FW) | 6, 12 and 18 months | |
Secondary | Visual function | Visual acuity, visual field, color vision and contrast sensitivity | 6, 12 and 18 months | |
Secondary | Optical coherence tomography (OCT) | Retinal thickness | 6, 12 and 18 months | |
Secondary | Rate and nature of adverse- and serious adverse events | Adverse events | 6, 12 and 18 months |
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