Status:
COMPLETED
Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS
Lead Sponsor:
Brainstorm-Cell Therapeutics
Conditions:
Multiple Sclerosis, Chronic Progressive
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 stu...
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 inclus...
Eligibility Criteria
Inclusion
- 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).
- Women of childbearing potential shall either be surgically sterile, or must agree not to become pregnant for the duration of the study. Women must be willing to undergo a serum pregnancy test at screening, and at the conclusion of the study. Participants of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study and for at least 3 months following the last transplantation. For those women who are sexually active and using oral contraceptives, a second form of barrier contraception is required. Men must be willing to consistently use two forms of contraceptive if their partners are of childbearing age.
- Capable of providing informed consent and willing and able to follow study procedures, including willingness to undergo multiple/repeated lumbar puncture.
Exclusion
- 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, in the opinion of the Investigator and the medical monitor, 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.
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03799718
Start Date
March 13 2019
End Date
March 30 2021
Last Update
December 4 2023
Active Locations (4)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Stanford University School of Medicine
Redwood City, California, United States, 94305
3
The Mount Sinai Hospital
New York, New York, United States, 10029
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195