Participating Hospitals
This clinical trial is being jointly conducted by The Third Affiliated Hospital of Sun Yat-sen University and The First Affiliated Hospital of Dalian Medical University, with Siser Biotech providing the investigational product. The study is recruiting eligible patients with spinal cord injury to participate in a registrational clinical trial of regenerative therapy for spinal cord injury using a clinical-grade induced pluripotent stem cell (iPSC)-derived subtype neural progenitor cell investigational new drug.
Basic Eligibility Criteria
Patients with spinal cord injury who meet the following criteria are eligible for screening. The inclusion criteria include, but are not limited to:
1.Age 18–65 years, inclusive; no restriction by sex.
2.Spinal cord injury caused by trauma or surgery-related injury, with the injured segment ranging from cervical C4 to lumbar L2.
3.American Spinal Injury Association (ASIA) impairment grade A, B, or C, with MRI confirmation of spinal cord injury.
4.The primary spinal cord injury occurred within 14–60 days before screening, with complete medical records required as documentation.
5.Patients of childbearing potential must agree to use effective non-pharmacological contraception during the trial and for 6 months after trial completion.
6.The patient must volunteer to participate, be able to understand and comply with the study procedures, and either the participant or their legal guardian must understand the trial content and sign the informed consent form.
Participant Benefits
Patients who successfully enroll in the trial will receive transportation subsidies and related research compensation.
Contact for Registration and Enquiries
● Enquiry hotline for the recruitment team at The Third Affiliated Hospital of Sun Yat-sen University: 16607590610, 15768990134, 17317916592
● Enquiry hotline for the recruitment team at The First Affiliated Hospital of Dalian Medical University: 18811288338
For details, see: https://www.zssy.com.cn/article/28760