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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

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 10, 2019
Last Update Posted Date January 11, 2019
Estimated Study Start Date  ICMJE February 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
Incidence of treatment-emergent adverse events [ Time Frame: Up to 28 weeks post-treatment ]
Safety of 3 intrathecal doses of NurOwn® (MSC-NTF cells)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03799718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • Timed 25-foot walking speed - 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • Timed 25-foot walking speed - change from baseline. [ Time Frame: 28 weeks ]
    Efficacy measure
  • Number of participants with changes in neurotrophic factors (such as VEGF and HGF) in the CSF following NurOwn® transplantation [ Time Frame: 16 weeks post tratment ]
    Efficacy measure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Open label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Chronic Progressive
Intervention  ICMJE Biological: NurOwn (MSC-NTF cells)
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
Study Arms  ICMJE Experimental: NurOwn (MSC-NTF cells)
Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
Intervention: Biological: NurOwn (MSC-NTF cells)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 9, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ralph Kern, MD 201-488-0460 rkern@brainstorm-cell.com
Contact: Yael Gothelf, Ph.D. +972-3-923-6384 ygothelf@brainstorm-cell.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03799718
Other Study ID Numbers  ICMJE BCT-101-US
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Undecided
Responsible Party Brainstorm-Cell Therapeutics
Study Sponsor  ICMJE Brainstorm-Cell Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Cohen, MD The Cleveland Clinic
PRS Account Brainstorm-Cell Therapeutics
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP