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Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis (SMART-MS)

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ClinicalTrials.gov Identifier: NCT04749667
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : September 8, 2021
Sponsor:
Collaborators:
University of Bergen
University Hospital Ulm
University Hospital, Akershus
St. Olavs Hospital
University Hospital of North Norway
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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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.

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Progressive Multiple Sclerosis Other: MSCs Drug: Saline Phase 1 Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective, randomized, placebo-controlled, cross-over study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis
Actual Study Start Date : August 9, 2021
Estimated Primary Completion Date : October 4, 2024
Estimated Study Completion Date : January 4, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A - Crossover with MSCs at baseline and placebo at 6 months
Receives mesenchymal stem cells at baseline and placebo at 6 months
 Other: MSCs
Autologous bone-marrow derived mesenchymal stem cells
Other Name: Mesenchymal stem cells

Drug: Saline
Isotonic saline
Experimental: Arm B - Crossover with placebo at baseline and MSCs at 6 months
Receives placebo at baseline and mesenchymal stem cells at 6 months
 Other: MSCs
Autologous bone-marrow derived mesenchymal stem cells
Other Name: Mesenchymal stem cells

Drug: Saline
Isotonic saline


Outcome Measures
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Primary Outcome Measures :
  1. Neurophysiological parameters - Combined evoked potentials [ Time Frame: 6 months ]
    Somatosensoric evoked potentials (SEP) + visual evoked potentials (VEP) + motor evoked potentials (MEP), latency (ms) and amplitude (mV)


Secondary Outcome Measures :
  1. Neurophysiological parameters - Somatosensoric evoked potantials [ Time Frame: 6 and 12 months ]
    SEP, latency (ms) and amplitude (mV)

  2. Neurophysiological parameters - Motor evoked potentials [ Time Frame: 6 and 12 months ]
    MEP, latency (ms) and amplitude (mV)

  3. Neurophysiological parameters - Visual evoked potentials [ Time Frame: 6 and 12 months ]
    VEP, latency (ms) and amplitude (mV)

  4. MRI-Lesion volumes [ Time Frame: 6 and 12 months ]
    T1- and T2-weighted hyperintense lesion volume

  5. MR- Brain volumes [ Time Frame: 6 and 12 months ]
    Brain volumes

  6. Expanded disability status scale [ Time Frame: 6, 12 and 18 months ]
    EDSS

  7. Patient reported outcomes (PROs) [ Time Frame: 6, 12 and 18 months ]
    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)

  8. Nine-Hole-Peg Test (9-HPT) [ Time Frame: 6, 12 and 18 months ]
    Nine-Hole-Peg Test (9-HPT)

  9. Timed 25 Foot Walk (T25FW) [ Time Frame: 6, 12 and 18 months ]
    Timed 25 Foot Walk (T25FW)

  10. Visual function [ Time Frame: 6, 12 and 18 months ]
    Visual acuity, visual field, color vision and contrast sensitivity

  11. Optical coherence tomography (OCT) [ Time Frame: 6, 12 and 18 months ]
    Retinal thickness

  12. Rate and nature of adverse- and serious adverse events [ Time Frame: 6, 12 and 18 months ]
    Adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04749667


Contacts
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Contact: Lars Bø, Prof 559750000 ext 0047 lars.bo@helse-bergen.no
Contact: Christopher Elnan Kvistad, PhD 559750000 ext 0047 echr@helse-bergen.no

Locations
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Norway
University hospital of North Norway Not yet recruiting
Tromsø, Troms Og Finnmark, Norway
Contact: Margitta Kampman, PhD    77626000 ext 0047    margitta.kampman@unn.no   
Principal Investigator: Margitta Kampman, PhD         
St.Olav university hospital Not yet recruiting
Trondheim, Trøndelag, Norway
Contact: Kristin Wesnes, PhD    72573000 ext 0047    Kristin.wesnes@stolav.no   
Principal Investigator: Kristin Wesens, PhD         
Haukeland University Hospital Recruiting
Bergen, Vestland, Norway
Contact: Christopher Elnan Kvistad, PhD    559750000    echr@helse-bergen.no   
Principal Investigator: Christopher Elnan Kvistad, PhD         
Akershus university hospital Not yet recruiting
Lørenskog, Viken, Norway
Contact: Trygve Hospital, Prof    67960000    trygve.holmoy@medisin.uio.no   
Principal Investigator: Trygve Holmøy, Prof         
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
University Hospital Ulm
University Hospital, Akershus
St. Olavs Hospital
University Hospital of North Norway
Investigators
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Principal Investigator: Lars Bø, Prof Haukeland University Hospital
More Information
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT04749667    
Other Study ID Numbers: 159326
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
Mesenchymal stem cells
Multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases