Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT04749667
Status:
UNKNOWN
Last Update Posted:
2023-09-11
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, randomized, placebo-controlled, cross-over study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-01-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurophysiological parameters - Combined evoked potentials', 'timeFrame': '6 months', 'description': 'Somatosensoric evoked potentials (SEP) + visual evoked potentials (VEP) + motor evoked potentials (MEP), latency (ms) and amplitude (mV)'}], 'secondaryOutcomes': [{'measure': 'Neurophysiological parameters - Somatosensoric evoked potantials', 'timeFrame': '6 and 12 months', 'description': 'SEP, latency (ms) and amplitude (mV)'}, {'measure': 'Neurophysiological parameters - Motor evoked potentials', 'timeFrame': '6 and 12 months', 'description': 'MEP, latency (ms) and amplitude (mV)'}, {'measure': 'Neurophysiological parameters - Visual evoked potentials', 'timeFrame': '6 and 12 months', 'description': 'VEP, latency (ms) and amplitude (mV)'}, {'measure': 'MRI-Lesion volumes', 'timeFrame': '6 and 12 months', 'description': 'T1- and T2-weighted hyperintense lesion volume'}, {'measure': 'MR- Brain volumes', 'timeFrame': '6 and 12 months', 'description': 'Brain volumes'}, {'measure': 'Expanded disability status scale', 'timeFrame': '6, 12 and 18 months', 'description': 'EDSS'}, {'measure': 'Patient reported outcomes (PROs)', 'timeFrame': '6, 12 and 18 months', 'description': '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)'}, {'measure': 'Nine-Hole-Peg Test (9-HPT)', 'timeFrame': '6, 12 and 18 months', 'description': 'Nine-Hole-Peg Test (9-HPT)'}, {'measure': 'Timed 25 Foot Walk (T25FW)', 'timeFrame': '6, 12 and 18 months', 'description': 'Timed 25 Foot Walk (T25FW)'}, {'measure': 'Visual function', 'timeFrame': '6, 12 and 18 months', 'description': 'Visual acuity, visual field, color vision and contrast sensitivity'}, {'measure': 'Optical coherence tomography (OCT)', 'timeFrame': '6, 12 and 18 months', 'description': 'Retinal thickness'}, {'measure': 'Rate and nature of adverse- and serious adverse events', 'timeFrame': '6, 12 and 18 months', 'description': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mesenchymal stem cells', 'Multiple sclerosis'], 'conditions': ['Multiple Sclerosis', 'Progressive Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary 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.', 'detailedDescription': 'Prospective, interventional, randomized, placebo-controlled, cross-over study. Patients are randomized to either treatment arm A or B.\n\nPatients in both treatment arms receive intrathecal autologous MSCs, arm A at baseline and arm B at six months.\n\nAll 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.\n\nAt 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.\n\nPrimary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 to ≤55, both genders\n2. Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS\n3. An EDSS score of 4 to 7\n4. Disease duration 2 - 15 years\n5. Signed, written informed consent\n\nExclusion Criteria:\n\n1. 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\n2. 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\n3. Current immunomodulatory/immunosuppressive treatment\n4. 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.\n5. Treatment with kladribin, ocrelizumab, rituximab, and alemtuzumab within 12 months prior to inclusion\n6. Treatment with hematopoietic stem cell therapy within 12 months prior to inclusion\n7. Treatment with glucocorticoids or ACTH within three months prior to start of inclusion\n8. Having experienced an MS relapse within 2 years prior to study inclusion\n9. Current treatment with fampridin\n10. 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\n11. Severely limited life expectancy by another co-morbid illness\n12. 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\n13. Immunocompromised patients\n14. Estimated glomerular filtration rate \\<60 ml/min/1.73 m2 or known renal failure\n15. Bleeding or clotting diathesis or the use of antithrombotic or anticoagulative treatment\n16. Platelet (thrombocyte) count \\<100 x 10\\*9/L\n17. Participation in another experimental clinical study within the preceding 12 months\n18. Contraindications to MRI\n19. Prior or current major depression\n20. 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.\n21. Pregnancy or risk of pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study), breastfeeding or lactation\n22. History of autologous/allogenic bone marrow transplantation or peripheral blood cell transplant\n23. Known hypersensitivity against paracetamol, codein or xylocain\n24. Diagnosis or strong suspicion of polyneuropathy\n25. Prior or current alcohol or drug dependencies\n26. Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04749667', 'acronym': 'SMART-MS', 'briefTitle': 'Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis', 'orgStudyIdInfo': {'id': '159326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A - Crossover with MSCs at baseline and placebo at 6 months', 'description': 'Receives mesenchymal stem cells at baseline and placebo at 6 months', 'interventionNames': ['Other: MSCs', 'Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B - Crossover with placebo at baseline and MSCs at 6 months', 'description': 'Receives placebo at baseline and mesenchymal stem cells at 6 months', 'interventionNames': ['Other: MSCs', 'Drug: Saline']}], 'interventions': [{'name': 'MSCs', 'type': 'OTHER', 'otherNames': ['Mesenchymal stem cells'], 'description': 'Autologous bone-marrow derived mesenchymal stem cells', 'armGroupLabels': ['Arm A - Crossover with MSCs at baseline and placebo at 6 months', 'Arm B - Crossover with placebo at baseline and MSCs at 6 months']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Isotonic saline', 'armGroupLabels': ['Arm A - Crossover with MSCs at baseline and placebo at 6 months', 'Arm B - Crossover with placebo at baseline and MSCs at 6 months']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lørenskog', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Akershus university hospital'}, {'city': 'Tromsø', 'state': 'Troms Og Finnmark', 'country': 'Norway', 'facility': 'University hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'city': 'Trondheim', 'state': 'Trøndelag', 'country': 'Norway', 'facility': 'St.Olav university hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Bergen', 'state': 'Vestland', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Christopher Elnan Kvistad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haukeland University Hospital'}, {'name': 'Lars Bø, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Haukeland University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bergen', 'class': 'OTHER'}, {'name': 'University Hospital Ulm', 'class': 'OTHER'}, {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'University Hospital of North Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}