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Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03799718
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : September 1, 2021
Information provided by (Responsible Party):
Brainstorm-Cell Therapeutics

Brief Summary:
A multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Chronic Progressive Biological: NurOwn (MSC-NTF cells) Phase 2

Detailed Description:
An open-label study with a single treatment arm involving 20 participants with progressive MS at multiple investigational study sites. After providing informed consent, participants meeting the inclusion and exclusion criteria will be randomized and approximately 4 weeks later will undergo a bone-marrow aspiration (BMA). Each participants will receive three Intrathecal cell transplantations within 16 weeks and will be followed for 12 weeks for safety and efficacy.

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NurOwn (MSC-NTF cells)
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
Biological: NurOwn (MSC-NTF cells)
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: Up to 28 weeks post-treatment ]
    Safety of 3 intrathecal doses of NurOwn® (MSC-NTF cells)

Secondary Outcome Measures :
  1. Timed 25-foot walking speed or 9-Hole Peg Test - change from baseline. [ Time Frame: 28 weeks ]
    Efficacy measure

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  1. Males and females ages 18 to 65 years old, inclusive, at the Screening Visit.
  2. 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.
  3. No evidence of clinical MS relapse or high dose pulse corticosteroid treatment within 6 months prior to screening
  4. Disability status at screening with an Expanded Disability Status Scale (EDSS) 3.0-6.5, inclusive.
  5. Able to walk 25 feet in 60 seconds or less.
  6. Stable dose of non-excluded MS Disease Modifying Therapy for at least 6 months prior to Screening Visit (Visit 1).

Exclusion Criteria:

  1. Prior stem cell therapy of any kind.
  2. 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).
  3. 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.
  4. 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.
  5. 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.
  6. 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)).
  7. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value >3.0 times the upper normal limit.
  8. Serum creatinine value >2.0 times the upper normal limit.
  9. 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.
  10. 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).
  11. Any history of acquired or inherited immune deficiency syndrome.
  12. Any history of either substance abuse within the past year, or unstable psychiatric disease according to the Investigator's judgment.
  13. Pregnant women or women currently breastfeeding.
  14. 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.

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 identifier (NCT number): NCT03799718

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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
Sponsors and Collaborators
Brainstorm-Cell Therapeutics
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Principal Investigator: Jeffrey Cohen, MD The Cleveland Clinic
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Responsible Party: Brainstorm-Cell Therapeutics 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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