Nerve Growth Factor Encapsulated With 2-methacryloyloxyethyl Phosphorylcholine Nanocapsules in the Treatment of Amyotrophic Lateral Sclerosis

Trial ID: NCT06391645

Interventional - Phase 2/3 - Not yet recruiting

Amyotrophic lateral sclerosis (ALS) is one of the most lethal neurodegenerative diseases, with most patients dying from respiratory failure 3-5 years after the onset. The purpose of this study is to explore the efficacy and safety of nerve growth factor (NGF) encapsulated with 2-methacryloyloxyethyl phosphorylcholine (MPC) nanocapsules in the treatment of ALS patients.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

• Nerve Growth Factor

Eligibility

Inclusion criteria

• 1. 18-80 years old;
• 2. Confirmed or possible familial or sporadic ALS diagnosed according to the revised El Escorial criteria;
• 3. 6 months ≤disease duration ≤ 3 years, (onset time is defined as the time of the first occurrence of myasthenia);
• 4. Forced vital capacity (FVC) ≥ 85% of predicted value (based on gender, height and age);
• 5. Informed consent signed.

Exclusion criteria

• 1. Patients undergoing endotracheal intubation, non-invasive or mechanical ventilation;
• 2. Patients with diaphragmatic pacemakers;
• 3. Allergy to any component of the investigational medication, or any other allergic history that researchers deem necessary to be vigilant about;
• 4. Local skin infection or other suspicious signs of infection at the injection site;
• 5. Known hemorrhagic tendency (including but not limited to: platelet count \<100×109/ L; on therapy of heparin, activated partial thromboplastin time (APTT) ≥35s; on therapy of warfarin, international normalized ratio (INR) \>1.7; on therapy of novel oral anticoagulants; with direct thrombin or factor Xa inhibitor; accompanied with coagulopathy such as hemophilia);
• 6. Severe cardiac insufficiency before randomization (comply with New York College of Cardiology (NYHA) Cardiac Function Class III, IV);
• 7. Suffering from infectious diseases: hepatitis, tuberculosis, acquired immunodeficiency syndrome, etc;
• 8. Psychiatric disorders diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria; or with suicidal intentions;
• 9. Women/men with desire to conceive during the experiment, and patients with pregnancy and lactation;
• 10. Difficulty in verbal communication, inability to communicate, understand or follow instructions, inability to cooperate with treatment and evaluation;
• 11. Combining with history of alcohol and drug abuse;
• 12. Unable to cooperate in follow-up due to geographical or other reasons;
• 13. Patients participated in other clinical trials or used other biologics, drugs, or devices under study.

Sponsor

Beijing Tiantan Hospital, Beijing University of Chemical Technology, Beijing Healthunion Cardio-Cerebrovascular Disease Prevention and Treatment Foundation

Source: ClinicalTrials.gov

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