Inclusion and exclusion criteria
hepatitis B, failure or intolerance, tuberculosis, immune deficiency
HEPATITIS B, CHRONIC INFECTION, DISEASE COURSE, PMS, DISEASE, TUBERCULOSIS, IMMUNE DEFICIENCY, SYNDROMES, HEPATITIS C
Cells used for transplant in patients derived from the expansion of the BI-0194-008 cell line performed at ‘Laboratorio di Terapia Cellulare e Genica Stefano Verri - ASST - Monza, Ospedale San Gerardo’ under GMP conditions with standard operating procedures (Supplementary Fig. Recruited patients were required to meet the following inclusion criteria: signature of the Informed Consent Form by the patient or patients’ legal guardians; age 18–55 years; diagnosis of PMS as per the revised McDonald 2010 criteria with a progressive course according to 2013 Lublin phenotypes classification with failure or intolerance to all approved therapies according to the disease course or without any alternative approved therapy; disease duration 2–20 years; EDSS ≥6.5; evidence of progression of the disease defined by an increase of ≥0.5 EDSS points in the last 12 months; and presence of OBs in the CSF required for PPMS. Exclusion criteria included: any active or chronic infection or disease other than MS including, but not limited to, HIV1-2, hepatitis B, hepatitis C, tuberculosis or immune deficiency syndromes; treatment with any immunosuppressive therapy within the 3 months before screening; treatment with interferon-beta, glatiramer acetate or corticosteroids within the 30 days before screening; a relapse occurred during the 30 days before screening; contraindications for or intolerance to any medications, treatments and procedures used in the study; pregnant or breastfeeding women or women of childbearing age who are not willing to use a contraceptive method effective for the entire duration of the study; and any condition that, in the opinion of the investigator, would preclude study participation.