Status:
RECRUITING
Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial
Lead Sponsor:
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Collaborating Sponsors:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Spinal Cord Injury
Safety
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This Phase I clinical trial is designed to evaluate the safety, tolerability of XS228 ( iPSC-Derived Motor Neuron Progenitor Cells) in patients with Subacute Spinal Cord Injury
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06976229
Start Date
July 2 2025
End Date
May 30 2028
Last Update
November 25 2025
Active Locations (1)
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1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630