Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALS

NO_LONGER_AVAILABLE

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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

Key facts

Study ID

NCT04681118

Run by

Brainstorm-Cell Therapeutics

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older, up to 63. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Able to safely undergo all study procedures.

You may not qualify if…

• 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.

Where it is running

• University of California Irvine Alpha Stem Cell Clinic — Irvine, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• UMass Medical School — Worcester, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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