Unrelated Umbilical Cord Blood Transplantation for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Exclusion Criteria

• •Patients with positive results in the following etiological tests: Human Immunodeficiency Virus (HIV-1/2), Human Cytomegalovirus DNA (HCMV-DNA), Epstein-Barr Virus DNA (EBV-DNA), Hepatitis B (positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B virus DNA (HBV-DNA)), Hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody (TP-Ab)
• •Clinically significant active bacterial, viral, fungal, or parasitic infections as judged by the investigator during screening
• •Patients who have previously received gene therapy or allogeneic hematopoietic stem cell transplantation
• •First-degree relatives with known or suspected familial cancer syndromes (including but not limited to hereditary breast and ovarian cancer syndrome, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis, etc.)
• •Diagnosis of major psychiatric disorders or predisposition to such conditions that would significantly impair the ability to participate in the clinical study
• •History of major organ impairment, including: Liver disorders: Liver function tests showing AST or ALT \>3 × ULN; total serum bilirubin \>2.5 × ULN; for cases consistent with Gilbert syndrome, total bilirubin \>3 × ULN and direct bilirubin \>2.5 × ULN; history of hepatic bridging fibrosis, cirrhosis, or active hepatitis; Cardiac disorders: Left ventricular ejection fraction (LVEF) \<45% at screening; New York Heart Association (NYHA) Class III or IV congestive heart failure; severe arrhythmias requiring treatment; poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg despite antihypertensive therapy), or prior history of hypertensive emergencies, hypertensive encephalopathy, or unstable angina; history of myocardial infarction, coronary artery bypass graft surgery, peripheral arterial bypass graft implantation, or stent placement within 12 months prior to enrollment; clinically significant valvular disease; calculated eGFR \<60 mL/min/1.73m²; Pulmonary function: FEV1/FVC \<60% and/or diffusing capacity less than 60% of predicted; clinically significant evidence of pulmonary hypertension requiring medical intervention
• •Uncorrectable coagulation dysfunction or history of severe bleeding disorders
• •Any other condition deemed by the physician to render the subject unsuitable for hematopoietic stem cell transplantation
• •Known hypersensitivity to the investigational drug or its components
• •Participation in or ongoing participation in other interventional clinical studies within 3 months prior to screening
• •Vaccination with live vaccines within 6 weeks prior to screening
• •Pregnant or breastfeeding women
• •History of solid organ transplantation
• •Poor compliance of the subject with the study protocol
• •Any other condition considered by the investigator as unsuitable for participation in this clinical trial
• •Unwillingness of the subject to provide pre-existing valid diagnostic evidence before treatment or to undergo bone marrow, lumbar puncture, blood tests, and other examinations after treatment