An Exploratory Study on the Use of Intrathecal Injection of Human Autologous Mesenchymal Stromal Cells Derived Extracellular Vesicles for the Treatment of Syringomyelia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a open-label, single-arm, dose escalation phase I clinical trial. The goal of this clinical trial is to evaluate the safety and preliminary efficacy of Intrathecal injection human umbilical cord-derived mesenchymal stromal cell-derived extracellular vesicle (hUC-MSC-sEV) in syringomyelia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Patients whose MR revealed that syrinx have shrunk after surgery for a year but whose clinical spinal cord symptoms have not improved.
• Patients whose MR revealed that syrinx spontaneously resolution under conservative observation, but whose clinical spinal cord symptoms have not improved.
• Age: 18-70 years, inclusion of both genders;
Locations
Other Locations
China
Xuanwu Hospital
RECRUITING
Beijing
Contact Information
Primary
fengzeng jian, md
jianfengzeng@xwh.ccmu.edu.cn
+861083198899
Backup
chenghua yuan
yuanchenghua@ccmu.edu.cn
+861083198899
Time Frame
Start Date: 2025-12-23
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 18
Treatments
Experimental: Exosomes group
Patients in this arm will receive exosomes derived from human umbilical cord blood mesenchymal stem cells as a Intrathecal injection, administered once a month, for a total of three months.
Related Therapeutic Areas
Sponsors
Collaborators: Yisaier Medical Technology (shan xi) Co., Ltd.
Leads: Xuanwu Hospital, Beijing