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

NCT04681118 | Unknown

• 1 other identifier: BCT-003-US
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 5

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

Conditions

Amyotrophic Lateral Sclerosis

Interventions

NurOwn (MSC-NTF cells) BIOLOGICAL

Intrathecal administration

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• \. Participation in the BCT-002-US study, successful completion of all scheduled treatments and follow-up assessments.
• 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:

• 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.
• 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.

Sponsors & Collaborators

• Brainstorm-Cell Therapeutics: lead

Study Sites (5)

University of California Irvine Alpha Stem Cell Clinic

Irvine, California, 92697, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

US (5)