Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS
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ClinicalTrials.gov Identifier: NCT03799718 |
Recruitment Status :
Completed
First Posted : January 10, 2019
Last Update Posted : September 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis, Chronic Progressive | Biological: NurOwn (MSC-NTF cells) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Open label |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MS |
Actual Study Start Date : | March 13, 2019 |
Actual Primary Completion Date : | March 11, 2021 |
Actual Study Completion Date : | March 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: NurOwn (MSC-NTF cells)
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
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Biological: NurOwn (MSC-NTF cells)
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
- Incidence of treatment-emergent adverse events [ Time Frame: Up to 28 weeks post-treatment ]Safety of 3 intrathecal doses of NurOwn® (MSC-NTF cells)
- Timed 25-foot walking speed or 9-Hole Peg Test - change from baseline. [ Time Frame: 28 weeks ]Efficacy measure
- Number of participants with changes in neurotrophic factors (such as Vascular endothelial growth factor and Hepatocyte growth factor) in the cerebrospinal fluid (CSF) following NurOwn® transplantation [ Time Frame: 16 weeks post treatment ]Efficacy measure

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females ages 18 to 65 years old, inclusive, at the Screening Visit.
- Clinical diagnosis of Progressive MS (Primary and Secondary) based on the 2017 revised MacDonald Criteria and confirmation by the Investigator that the disease has entered the progressive stage for at least 6 months prior to enrollment.
- No evidence of clinical MS relapse or high dose pulse corticosteroid treatment within 6 months prior to screening
- Disability status at screening with an Expanded Disability Status Scale (EDSS) 3.0-6.5, inclusive.
- Able to walk 25 feet in 60 seconds or less.
- Stable dose of non-excluded MS Disease Modifying Therapy for at least 6 months prior to Screening Visit (Visit 1).
Exclusion Criteria:
- Prior stem cell therapy of any kind.
- Active participation in any other MS interventional study or use of unapproved MS investigational therapy within 90 days prior to the Screening Visit (Visit 1).
- Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow biopsy, or inability to tolerate study procedures for any other reason.
- History of clinically significant autoimmune disease (excluding thyroid disease) that may confound study results, myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis.
- Any unstable clinically significant medical condition other than multiple sclerosis (e.g., within six months of Screening Visit (Visit 1), had myocardial infarction, angina pectoris, and/or congestive heart failure), treatment with anticoagulants that, in the opinion of the investigator, would compromise the safety of participants.
- Any history of malignancy within the previous 5 years, except for non-melanoma localized skin cancers (with no evidence of metastasis, significant invasion, or reoccurrence within three years of Screening Visit (Visit 1)).
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value >3.0 times the upper normal limit.
- Serum creatinine value >2.0 times the upper normal limit.
- Positive test for Hepatitis B (HBV; surface antigen (HBsAg) and antibodies to core antigen (IgG and IgM anti-HBc)), Hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
- Current use of immunosuppressant medication or use of such medication within 6 months of study enrollment (aside from Rituximab or other approved B-cell immunotherapy). Alemtuzumab (Lemtrada), Cladribine (NDA submitted), Natalizumab (Tysabri), S1P modulators (Gilenya) are excluded for safety reasons due to the known risk of systemic autoimmune disease, malignancy, opportunistic infections, and cardiovascular toxicity associated with these therapies, as well as theoretical effects on MSC-NTF cell homing and migration, that may be associated with Natalizumab and/or S1P modulators (Gilenya).
- Any history of acquired or inherited immune deficiency syndrome.
- Any history of either substance abuse within the past year, or unstable psychiatric disease according to the Investigator's judgment.
- Pregnant women or women currently breastfeeding.
- Subjects for whom MRI is contraindicated (i.e., have a pacemaker or other metallic implanted device, or are unable to remain in the machine for period of time needed to acquire a scan.

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): NCT03799718
United States, California | |
University of Southern California | |
Los Angeles, California, United States, 90033 | |
Stanford University School of Medicine | |
Redwood City, California, United States, 943063 | |
United States, New York | |
The Mount Sinai Hospital | |
New York, New York, United States, 10029 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Jeffrey Cohen, MD | The Cleveland Clinic |
Responsible Party: | Brainstorm-Cell Therapeutics |
ClinicalTrials.gov Identifier: | NCT03799718 |
Other Study ID Numbers: |
BCT-101-US |
First Posted: | January 10, 2019 Key Record Dates |
Last Update Posted: | September 1, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |