Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis

Korábbi kezelés

• Documented clinical relapse during the 24 months prior to enrollment and/or evidence of enhancing lesions on an MRI obtained at screening.
• Participants with history or current alcohol abuse or drug addiction.
• Participation in another research study involving an investigational product (IP) in the 90 days prior to inclusion, or planned use of another IP during the study duration.
• Participants who have ever received NG01/MSCs treatment.

Más betegség

• History of a general chronic handicapping/incapacitating disease other than MS.
• Participants with clotting disorders
• Participants with uncontrolled hepatic disorders, renal or cardiovascular disease, or cancer.
• Untreated or uncontrolled psychiatric disorders, or positive suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
• Less than 6 months of the current disease-modifying therapy

Laborértékek

• Laboratory tests out of normal ranges considered by the investigator as clinically significant.

Egyéb

• Pregnancy, breast feeding or women with childbearing potential without an acceptable form of contraception.
• Participants unable to undergo an MRI scan.
• Participants who, in the opinion of the investigator, are unable to fully comprehend the consenting process or likely to be non-compliant with the study procedures or for whom long-term follow-up seems difficult to achieve.
• Relapse occurring between screening and randomization.

• Participants aged 18 to 65 years old.
• Diagnosis of SPMS.
• Documented EDSS worsening over the 2 years prior to study entry of ≥1 point for participants with EDSS <6.0 at screening, and ≥0.5 point for participants with EDSS ≥6.0 at screening, or a documented worsening of at least 20% in the T25FW. If documented T25fW or EDSS is not available, a written summary of the clinical evidence of disability worsening over the previous 2 years and retrospective assessment of EDSS score from data up to 2 years prior to screening, must be submitted for central review by adjudication committee.
• EDSS at the screening visit from 3.5 to 6.5 at screening.
• T25FW at the screening visit of from 8.0 to 25 seconds.