Actively Recruiting
Extracellular Vesicles for the Treatment of Syringomyelia
Led by Xuanwu Hospital, Beijing · Updated on 2026-02-06
18
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
Y
Yisaier Medical Technology (shan xi) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Extracellular Vesicles for the Treatment of Syringomyelia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients whose MRI showed syrinx shrinkage after surgery for at least one year but with ongoing spinal cord symptoms
- Patients whose MRI showed spontaneous resolution of syrinx under observation but with ongoing spinal cord symptoms
- Age between 18 and 70 years, any gender
You will not qualify if you...
- Having diabetes, heart disease, or impaired liver or kidney function
- Having brainstem tumors or spinal cord tumors
- Infection at the lumbar puncture site
- Previous or current heart abnormalities
- Having autoimmune diseases requiring immunosuppressant treatment
- Allergy to study drugs
- Participation in other interventional studies or receiving cell therapies (except blood transfusion) within the past three months
- Being unconscious or unable to cooperate with neurological tests or treatment
- Pregnant, breastfeeding, or planning pregnancy
- Positive serological tests for HBsAg, anti-HCV, anti-HIV, or TP-Ab
- Other conditions deemed unsuitable by the researcher, including poor compliance or abnormal lab tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital
Beijing, Beijing City, China, 100032
Actively Recruiting
Research Team
F
fengzeng jian, md
CONTACT
C
chenghua yuan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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