Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT06974968
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 to 65 years (inclusive), regardless of gender.
Etiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors.
Severity:
Classified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury.
Disease Stage:
Primary SCI occurring 14 to 60 days prior to screening (subacute phase).
Contraception:
Participants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion.
Compliance:
Voluntarily participate in the clinical study. Ability to understand and comply with study procedures. Participant or legal guardian can provide written informed consent.
Exclusion Criteria:
* Neurological Inability
Primary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment.
Respiratory/Circulatory Instability
High cervical SCI (C1-C3) causing respiratory/circulatory compromise requiring endotracheal intubation or tracheostomy.
Life-Threatening Multiorgan Dysfunction
Concurrent severe injuries to other organ systems with life-threatening dysfunction.
Unstable Thoracoabdominal Injuries
Injuries to lungs, liver, kidneys, spleen, etc., deemed unstable by the investigator.
Prior Spinal Pathology
History of SCI or coexisting spinal disorders (e.g., ankylosing spondylitis, spinal deformities, primary/metastatic spinal tumors, spinal vascular malformations, syringomyelia).
Local Infection/Increased ICP
Active infection at the lumbar puncture site or intracranial hypertension during screening.
Severe Infections
Sepsis, septic shock, or severe pneumonia (per IDSA/ATS 2007 diagnostic criteria).
Confounding Neurological/Psychiatric Conditions
Parkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, diabetic neuropathy, or other conditions interfering with study assessments.
Cardiac Abnormalities (any of the following):
Congestive heart failure (NYHA Class III/IV). Severe uncontrolled arrhythmias (e.g., sick sinus syndrome, third-degree AV block).
Unstable angina or acute myocardial infarction within 3 months prior. Pulmonary Complications
Pulmonary hypertension, pulmonary embolism, or suspected embolism during screening.
Uncontrolled Hypertension/Hypotension
Systolic BP \>160 mmHg or diastolic BP \>100 mmHg; or systolic BP \<90 mmHg or diastolic BP \<60 mmHg.
Active Autoimmune Diseases
Requiring immunosuppressants (e.g., uncontrolled hyperthyroidism, systemic lupus erythematosus).
Immunosuppressant Non-Compliance
Unwillingness or inability to use immunosuppressants per protocol.
Laboratory Abnormalities (any of the following):
ALT/AST \>2×ULN or total bilirubin \>2×ULN. eGFR \<60 mL/min/1.73m² (CKD-EPI 2021 formula). APTT/PT \>2.5×ULN (without anticoagulants). Platelets \<100×10⁹/L or hemoglobin \<90 g/L. Allergy
History of severe allergies or hypersensitivity to trial drug/excipients (human albumin, lactated Ringer's solution).
Infectious Diseases
HBsAg+ with HBV DNA \>1000 IU/mL; HCV-Ab+; HIV-Ab+; or TP-Ab+. Lumbar Puncture Refusal
Unwillingness to undergo intrathecal administration procedures. Pregnancy/Lactation
Females who are pregnant or breastfeeding. Malignancy
Active malignancy or anticancer therapy within 5 years prior. Recent Clinical Trial Participation
Enrollment in another drug trial within 3 months prior. Investigator Discretion
Any condition deemed unsuitable for participation by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06974968
Study Brief:
Protocol Section:
NCT06974968