Status:
NO_LONGER_AVAILABLE
Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALS
Lead Sponsor:
Brainstorm-Cell Therapeutics
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-63 years
Brief Summary
Expanded Access for treatment with investigational product MSC-NTF cells(NurOwn®) for participants who completed all scheduled treatments and follow-up assessments in the BCT-002-US study
Detailed Description
This is an Intermediate-size patient population Expanded Access Protocol (EAP) to provide NurOwn® (MSC-NTF cells) for eligible ALS participants who completed the BCT-002-US phase 3 ALS clinical trial ...
Eligibility Criteria
Inclusion
- 1\. Participation in the BCT-002-US study, successful completion of all scheduled treatments and follow-up assessments.
- 2 Able to provide to the Investigator written informed consent regarding the investigational drug, or, as applicable, on whose behalf a legally authorized representative of the participant has provided such consent.
- 3\. Able to safely undergo all study procedures.
Exclusion
- Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow biopsy, or inability to tolerate treatment procedures for any other reason (lying flat with BiPAP or NIV are not exclusionary).
- History of clinically significant autoimmune disease (excluding thyroid disease) myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis.
- Any unstable clinically significant medical condition other than ALS (e.g., within six months of baseline, 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 the participant.
- Any history of malignancy within the previous 5 years, with the exception of non- melanoma localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline).
- Current use of immunosuppressant medication or use of such medication within 4 weeks of the pre-treatment visit.
- Any history of acquired or inherited immune deficiency syndrome.
- Tracheostomy and/or mechanical ventilation. Feeding tube use, BiPAP or NIV are not exclusionary.
- Pregnant women or women currently breastfeeding or unwilling to use effective birth control methods during the treatment (if of childbearing age).
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04681118
Last Update
April 23 2024
Active Locations (5)
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1
University of California Irvine Alpha Stem Cell Clinic
Irvine, California, United States, 92697
2
California Pacific Medical Center
San Francisco, California, United States, 94115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
4
UMass Medical School
Worcester, Massachusetts, United States, 01655