An Open, Single-Arm, Multi-Center Clinical Study to Evaluate the Safety and Tolerability of Regulatory T Cells (Tregs) In the Treatment of Neurodegenerative Diseases
An open, multi- center phase Ⅰ clinical study evaluating the safety and efficacy of autologous human polyclonal regulatory T cell injection (NP001 cell injection) in patients with Neurodegenerative diseases (ALS).
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‣ Patients must meet all of the following criteria to be eligible for enrollment in this study:
• Male or female patients aged 18 to 70 years;
• According to current international diagnostic criteria:
• ALS: defined by the Gold Coast Diagnostic Criteria (Shefner, 2020) as having a diagnosis of sporadic or familial amyotrophic lateral sclerosis (ALS), diagnosed as a probable, probable, or definite patient with laboratory support according to the World Federation of Neurology El Escorial criteria;
• If there is a stable dose for more than one month prior to study entry. For example, patients with ALS can continue treatment with riluzole (Rilutek®) and/or edaravone (Radicava®);
• Patients must have \> two weeks after the end of major surgery and after the completion of participation in other research trials;
• Patients must have recovered from clinical toxicity (CTCAE \[5th Edition\] toxicity values have resolved to \< 2);
• Serum creatinine less than or equal to 2.0 mg/dL;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal;
• Bilirubin \< 1.5 (except Gilbert's disease);
• Lung slow vital capacity (SVC) \> 70% of predicted normal;
⁃ No history of abnormal bleeding tendency;
⁃ Informed consent must be obtained prior to performing any study-related procedures that are not part of standard medical care, with the understanding that the participant may withdraw from the study without influence for the future medical care.