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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 : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Brainstorm-Cell Therapeutics

Study Description
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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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 - 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


Eligibility Criteria
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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
Criteria

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 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 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.
  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. Current use of immunosuppressant medication or use of such medication within 6 months of study enrolment (aside from approved B-cell immunotherapy).
  8. Any history of acquired or inherited immune deficiency syndrome.
  9. Exposure to any other experimental agent (off-label use or investigational) or participation in a clinical trial within 90 days prior to Screening Visit (Visit 1).
  10. Pregnant women or women currently breastfeeding.
  11. Subjects for whom MRI is contraindicated (i.e., have a pacemaker or other metallic implanted device, are allergic to gadolinium, or are unable to remain in the machine for period of time needed to acquire a scan.
  12. Positive test result for Hepatitis B virus (HBV; surface antigen (HBsAg) and IgM antibodies to core antigen (IgM anti-HBc)), Hepatitis C virus (HCV), Human Immune deficiency Virus (HIV) 1 and 2.
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): NCT03799718


Contacts
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Contact: Ralph Kern, MD 201-488-0460 rkern@brainstorm-cell.com
Contact: Yael Gothelf, Ph.D. +972-3-923-6384 ygothelf@brainstorm-cell.com

Sponsors and Collaborators
Brainstorm-Cell Therapeutics
Investigators
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Principal Investigator: Jeffrey Cohen, MD The Cleveland Clinic
More Information
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Responsible Party: Brainstorm-Cell Therapeutics
ClinicalTrials.gov Identifier: NCT03799718     History of Changes
Other Study ID Numbers: BCT-101-US
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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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