Post-Spinal Cord Injury Pain
Conditions
Interventions
Experimental group:Intracranial Injection of GA008
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients clinically diagnosed with post-spinal cord injury pain by the investigator, aged 18 to 65 years (regardless of gender), and: (1). Failed to achieve symptom relief or developed tolerance after receiving standardized conventional medical treatments (including but not limited to pharmacotherapy, physical therapy, cognitive therapy, nerve blockades, and other non-invasive or minimally invasive treatments) for at least 3 months, as assessed by the investigator. (2). Received at least two first-line medications at full dosage and course, as evaluated by the investigator. 2.Mean Visual Analog Scale (VAS) >=4 cm and/or Numerical Rating Scale (NRS) >=4 points within the baseline one-week period at enrollment; 3.As assessed by the investigator, the participant had a stable analgesic regimen for at least 30 days prior to the pain intensity described in Inclusion Criteria 2, and agrees not to arbitrarily change the type or dosage of current medications until the end of the trial's efficacy assessment period; 4.The participant voluntarily agrees to participate in the trial and signs the informed consent form with full understanding; 5.Stable neurological status, assessed by the investigator via motor, sensory, and reflex functions; 6.As judged by the investigator, the participant is considered reliable and capable of complying with the trial protocol (e.g., understanding and completing relevant scales), visit schedule, and medication administration; 7.Participants of childbearing potential agree to have no plans for pregnancy and voluntarily adopt effective contraceptive measures (oral contraceptives are prohibited), as well as no plans for sperm/egg donation, from the time of signing the informed consent form throughout the study period.
Exclusion criteria
Exclusion criteria: 1.Pain caused by non-spinal cord injury etiologies; 2.Coexisting non-painful complications related to spinal cord injury (including but not limited to moderate to severe muscle spasm [Modified Ashworth Scale >= Grade 2], neurogenic bowel dysfunction [requiring regular laxative use], recurrent urinary tract infections [>=2 episodes of bacteriuria in the past 6 months], or autonomic dysreflexia); 3.Conditions where spinal cord compression can be relieved by surgery or radiotherapy; 4.Current diagnosis of progressive neurological diseases, such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, brain or spinal cord tumors, neurodegenerative diseases, etc., as determined by the investigator; 5.Chronic systemic diseases that, as assessed by the investigator, may affect the participant’s ability to participate in the study, including but not limited to: (1). Severe cardiorespiratory diseases, such as unstable angina, myocardial infarction, severe arrhythmia, recurrent asthma, etc.; (2). Malignant tumors of the central nervous system or other systems. 6.Current status of coagulation dysfunction, bleeding tendency, platelet dysfunction, or severe decline in physiological reserve due to peripheral vascular disease or poorly controlled diabetes, as assessed by the investigator to have diseases affecting surgery. 7.Currently taking anticoagulant medications and unable to discontinue them; 8.Expected local infection at the surgical approach site or active systemic infection; 9.History of intracranial surgery (except for minimally invasive puncture for diagnostic purposes); 10.Patients with severe mental symptoms (such as schizophrenia) or obvious suicidal tendencies, who are assessed by the investigator as unable to complete the clinical trial; 11.History or presence of severe hepatic insufficiency, renal insufficiency, cardiac insufficiency (where severe hepatic insufficiency is defined as ALT = 3.0 × upper limit of normal [ULN] or AST >= 3.0 × ULN; severe renal insufficiency is defined as creatinine [CRE] >= 1.5 × ULN or eGFR 1.5×ULN; (4). Blood adeno-associated virus (AAV) antibody titer > 1:1000. 13.Patients currently taking medications causing agranulocytosis or bone marrow suppression; 14.Patients with a history of agranulocytosis or severe granulocytopenia caused by clozapine; 15.Patients with contraindications and/or allergies to study medications (such as GA008 injection, clozapine or its components, contrast agents, etc.); 16.Digestive system diseases affecting drug absorption, metabolism, or excretion (Crohn’s disease, acute or chronic pancreatitis, paralytic ileus, etc.) or major digestive system surgeries; 17.Participants who have received any gene or cell therapy; 18.Known history of alcohol or drug abuse; 19.Participants who have participated in other clinical trials or used investigational biologics, drugs, or devices within the past six months before screening; 20.Contraindications to MRI and functional MRI (such as claustrophobia, metallic f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events within 28 days after participants receive GA008 injection will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events during the Efficacy Exploration Period (Dose Exploration Phase and Efficacy Observation Phase);Visual Analogue Scale;Daily Sleep Interference Scale;Insomnia Severity Index;Hamilton Anxiety Rating Scale;Hamilton Depression Rating Scale;Patient Global Impression of Change;EuroQol 5-Dimension 5-Level;Montreal Cognitive Assessment; | — |
Countries
China
Contacts
Public ContactWanru Duan
Xuanwu Hospital, Capital Medical University
Outcome results
None listed