Status:
NOT_YET_RECRUITING
Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in Subacute Ischemic Stroke
Lead Sponsor:
Shanghai IxCell Biotechnology Co., LTD
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the...
Detailed Description
This study aims to further evaluate the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in the treatment of stroke. Eligible participants will be randomized to re...
Eligibility Criteria
Inclusion
- Age ≥18 years and ≤70 years, regardless of gender.
- 14 to 90 days after ischemic stroke.
- Clinical diagnosis of anterior circulation ischemic stroke.
- National Institutes of Health Stroke Scale (NIHSS) score is 6-20 points (inclusive), with NIHSS motor arm (item 5) or motor leg (item 6) score of 2-4 points, and NIHSS level of consciousness item (1a) score \<2 points.
- It was anticipated that participants would either be able to give informed consent or have a legal representative who could do so.
Exclusion
- People who had a history of epilepsy, dementia, Parkinson's disease, severe depression, or other neurological or psychiatric disorders.
- Intracranial hemorrhagic conditions.
- Pre-stroke mRS score \>1.
- Severe cardiovascular disease.
- Severe pulmonary diseases.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT07197606
Start Date
October 1 2025
End Date
December 31 2027
Last Update
September 29 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China