Actively Recruiting
Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial
Led by XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · Updated on 2025-11-25
12
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
X
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Lead Sponsor
T
Third Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years, any gender
- Spinal cord injury from cervical (C4) to lumbar (L2) caused by trauma or surgery
- Classified as ASIA Impairment Scale Grades A, B, or C with MRI confirmation
- Primary spinal cord injury occurring 14 to 60 days before screening
- Agreement to use effective non-hormonal contraceptive methods during and for 6 months after the trial if of childbearing potential
- Willingness and ability to participate and comply with study procedures and provide informed consent
You will not qualify if you...
- Severe traumatic brain injury preventing neurological assessment
- High cervical SCI (C1-C3) requiring respiratory support such as intubation or tracheostomy
- Severe life-threatening injuries to other organs
- Unstable injuries to lungs, liver, kidneys, spleen, or other thoracoabdominal organs
- History of spinal disorders like ankylosing spondylitis, spinal tumors, or vascular malformations
- Active infection at lumbar puncture site or intracranial hypertension
- Severe infections such as sepsis or pneumonia
- Neurological or psychiatric diseases interfering with study assessments
- Severe heart problems including congestive heart failure or uncontrolled arrhythmias
- Recent unstable angina or heart attack within 3 months
- Pulmonary hypertension or embolism
- Blood pressure outside specified safe ranges
- Active autoimmune diseases requiring immunosuppressants
- Unwillingness or inability to use immunosuppressants as required
- Abnormal liver or kidney function tests beyond set limits
- History of severe allergies to study drug components
- Positive tests for active hepatitis B, hepatitis C, HIV, or syphilis
- Refusal to undergo lumbar puncture
- Pregnant or breastfeeding females
- Active cancer or cancer treatment within 5 years
- Participation in another drug trial within 3 months
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
Research Team
M
Michael LEE
CONTACT
M
Mao Pang, prof and M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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