2023-510228-63-00Not yet recruitingPhase 2
Study of Mesenchymal Autologous stem cells as Regenerative Treatment for Multiple Sclerosis (SMART-MS)
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Helse Bergen HF
- Enrollment
- 18
- Locations
- 4
- Primary Endpoint
- Difference in CEP (VEP+SEP+MEP) at 6 months as compared to baseline between MSCs treatment vs. placebo (arm A vs. arm B)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 to ≤55, both genders
- •Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS
- •An EDSS score of 4 to 7
- •Disease duration 2 - 18 years
- •Signed, written informed consent
Exclusion Criteria
- •Treatment with cytotoxic medications during the last 3 months prior to inclusion
- •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 within the last 10 years
- •Severely limited life expectancy by another co-morbid illness
- •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
- •Immunocompromised patients
- •Estimated glomerular filtration rate <60 ml/min/1.73 m2 or known renal failure
- •Bleeding or clotting diathesis or the use of antithrombotic or anticoagulative treatment
- •Platelet (thrombocyte) count <100 x 10*9/L
- •Participation in another experimental clinical study with administration of another IMP within the preceding 12 months
- •Contraindications to MRI
- •Prior or current major depression
- •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
- •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.
- •Pregnancy or risk of pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study), breastfeeding or lactation
- •Known hypersensitivity against paracetamol, codein or xylocain
- •Diagnosis or strong suspicion of polyneuropathy
- •Prior or current alcohol or drug dependencies
- •Inability to give informed consent
- •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
- •Current immunomodulatory/immunosuppressive treatment
- •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.
- •Treatment with kladribin, ocrelizumab, rituximab, and alemtuzumab within 12 months prior to inclusion
- •Treatment with hematopoietic stem cell therapy within 12 months prior to inclusion
- •Treatment with glucocorticoids or ACTH within three months prior to start of inclusion
- •Having experienced an MS relapse within 2 years prior to study inclusion
Outcomes
Primary Outcomes
Difference in CEP (VEP+SEP+MEP) at 6 months as compared to baseline between MSCs treatment vs. placebo (arm A vs. arm B)
Difference in CEP (VEP+SEP+MEP) at 6 months as compared to baseline between MSCs treatment vs. placebo (arm A vs. arm B)
Secondary Outcomes
- Difference in CEP at 12 months (study treatment 1 vs. study treatment 2)
- Difference in VEP at 6 months (arm A vs. arm B)
- Difference in VEP at 12 months (study treatment 1 vs. study treatment 2)
- Difference in SEP at 6 months (arm A vs. arm B)
- Difference in SEP at 12 months (study treatment 1 vs. study treatment 2)
- Difference in MEP at 6 months (arm A vs. arm B)
- Difference in MEP at 12 months (study treatment 1 vs. study treatment 2)
- Difference in EDSS at 6 months (arm A vs. arm B)
- Difference in EDSS at 12 months (study treatment 1 vs. study treatment 2)
- Difference in MRI T2-weighted hyperintense lesion volume at 6 months (arm A vs. arm B)
- Difference in MRI T2-weighted hyperintense lesion volume at 12 months (study treatment 1 vs. study treatment 2)
- Difference in MRI T1-weighted hypointense lesion volume at 6 months (arm A vs. arm B)
- Difference in MRI T1-weighted hypointense lesion volume at 12 months (study treatment 1 vs. study treatment 2)
- Difference in brain volume at 6 months (arm A vs. arm B)
- Difference in brain volume at 12 months (study treatment 1 vs. study treatment 2)
- Difference in visual function (visual acuity, visual field, color vision and contrast sensitivity) at 6 months (arm A vs. arm B)
- Difference in visual function (visual acuity, visual field, color vision and contrast sensitivity) at 12 months (study treatment 1 vs. study treatment 2)
- Difference in retinal thickness measured with OCT at 6 months (arm A vs. arm B)
- Difference in retinal thickness measured with OCT at 12 months (study treatment 1 vs study treatment 2)
- Difference in Nine-Hole-Peg Test (9-HPT) score at 6 months (arm A vs. arm B)
- Difference in Nine-Hole-Peg Test (9-HPT) score at 12 months (study treatment 1 vs. study treatment 2)
- Difference in Timed 25 Foot Walk (T25FW) score at 6 months (arm A vs. arm B)
- Difference in Timed 25 Foot Walk (T25FW) score at 12 months (study treatment 1 vs. study treatment 2)
- Difference in the 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) score at 6 months (arm A vs. arm B)
- Difference in the 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) score at 12 months (study treatment 1 vs. study treatment 2)
- Difference in serum neurofilament light chain and GFAP at 6 months (arm A vs. arm B)
- Difference in serum neurofilament light chain and GFAP at 12 monhts (study treatment 1 vs. study treatment 2)
- Intraindividual CEP (longitudinal) between study treatment 1 vs. study treatment 2 in each patient
- Rate and nature of adverse- and serious adverse events during 18 months of follow up
- Clinical relevant changes in vital signs during 18 months of follow up
- Clinical relevant changes on physical examinations during 18 months of follow up
- Clinical relevant changes in clinical laboratory results during 18 months of follow up
Investigators
Christopher Elnan Kvistad
Scientific
Helse Bergen HF
Study Sites (4)
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