Ensayos clínicos

Inclusion Criteria:

• Participation in the BCT-002-US study, completed all study visits and have received three IT treatments.
• Able to provide to the Investigator written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the participant has provided such consent.
• Able to safely undergo a bone marrow aspiration.
• Feeding tube use is permitted.

Exclusion Criteria:

• Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow aspiration, or inability to tolerate treatment procedures for any other reason (lying flat with BiPAP or NIV is 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 nonmelanoma 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 screening visit.
• Any history of acquired or inherited immune deficiency syndrome.
• Tracheostomy and/or mechanical ventilation (BiPAP or NIV are not exclisonary).
• 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.