Natural history of Chiari I malformation-syringomyelia: longitudinal cohort study.
Chenghua Yuan, Yueqi Du, Qingyu Yao...
https://pubmed.ncbi.nlm.nih.gov/40675800Actively Recruiting
Phase 1
Age: 18Years - 70Years
All Genders
ID07295067
Exploratory Study of Intrathecal Injection of Human Umbilical Cord Mesenchymal Stromal Cell-Derived Extracellular Vesicles for Syringomyelia
Led by Xuanwu Hospital, Beijing · Updated on 2026-02-06
18
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety and early effects of human umbilical cord-derived mesenchymal stromal cell-derived extracellular vesicles (hUC-MSC-sEV) delivered by intrathecal injection for people with syringomyelia. This open-label, single-arm phase I trial uses a dose-escalation design to find the best dose and assess potential risks. The study is sponsored by Xuanwu Hospital, Beijing, and aims to improve treatment options for this condition. Participants will receive one of three dose levels of hUC-MSC-sEV particles through a lumbar puncture once a month for three months. The doses range from low to high, with 2 ml administered each time. If no serious side effects are seen, the dose will increase in new participant groups. If dose-limiting toxicities occur, the study may adjust or stop dose escalation accordingly. During the study, participants will undergo neurological assessments, imaging, and safety checks at multiple intervals, including 4, 8, and 12 weeks, as well as at 12 months. Researchers will monitor for dose-limiting toxicities and evaluate functional scores related to spinal cord injury and syringomyelia progression. Participants are closely followed to observe any serious adverse events and overall treatment impact over one year.
CONDITIONS
Brief Title
Extracellular Vesicles for the Treatment of Syringomyelia
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with MRI showing syrinx shrinkage after surgery for one year but no improvement in spinal cord symptoms
- Patients with MRI showing spontaneous syrinx resolution but persistent spinal cord symptoms
- Age between 18 and 70 years
- Both genders eligible
You will not qualify if you...
- Diabetes, heart disease, or impaired liver or kidney function
- Brainstem tumors or spinal cord tumors
- Infection at lumbar puncture site
- Known or previous heart abnormalities
- Autoimmune diseases requiring immunosuppressant treatment
- Allergy to study drugs
- Participation in other interventional studies or cell therapies within past three months (excluding blood transfusion)
- Unconsciousness or inability to cooperate with neurological tests
- Long-term drug treatment with poor compliance
- Pregnant, breastfeeding, or planning pregnancy
- Positive serological tests for HBsAg, anti-HCV, anti-HIV, or TP-Ab
- Other factors deemed unsuitable by the researcher, including poor compliance or abnormal lab tests
- Misdiagnosis
- Use of medications impacting study assessment
- Missing evaluation outcomes during follow-up
- Serious adverse events related to study treatment
- Protocol errors requiring trial halt
- National regulatory requirements to stop the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive intrathecal injections of exosomes derived from human umbilical cord blood mesenchymal stem cells once a month for a total of three months at the dose level assigned during dose escalation.
3 monthly visits (in-person) for injections
Follow-up
Duration - Up to 12 months
Participants are monitored for safety and effectiveness, including assessments of neurological function and syrinx status, for up to 12 months after treatment.
Visits at approximately 4, 8, 12 weeks and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital
Beijing, Beijing City, China, 100032
Actively Recruiting
Loading map...
Research Team
F
fengzeng jian, md
C
chenghua yuan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
First-In-Human Application of Human Umbilical Cord-Derived Extracellular Vesicles in Tethered Spinal Cord Release Surgery.
Matthias Krause, Janina Gburek-Augustat, Daniel Gräfe...
https://pubmed.ncbi.nlm.nih.gov/40536443Cell therapy with autologous mesenchymal stromal cells in post-traumatic syringomyelia.
Jesús Vaquero, Mercedes Zurita, Miguel A Rico...
https://pubmed.ncbi.nlm.nih.gov/29784434Treatment of Syringomyelia Characterized by Focal Dilatation of the Central Canal Using Mesenchymal Stem Cells and Neural Stem Cells.
Mo Li, Xinyu Wang, Boling Qi...
https://pubmed.ncbi.nlm.nih.gov/38578425