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A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke
Sponsor: BOE Technology Group Co., Ltd.
Summary
Study Methods: The trial consists of two phases, both including a placebo control. Phase Ia (single-dose, dose-escalation): Three dose groups (low, medium, high) are set. This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial. Dose escalation to the next level is permitted only after safety assessment at 28 days post-dose in the previous group. Phase Ib (multiple-dose): Based on Phase Ia results, two dose groups will be selected. The product is administered on Day 0, Day 7, and Day 14 (3 doses total). The trial remains randomized, double-blind, and placebo-controlled.
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord-derived Mesenchymal Stromal Cell Injection in Patients With Acute Ischemic Stroke (AIS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2026-06-30
Completion Date
2029-11-30
Last Updated
2026-06-05
Healthy Volunteers
No
Conditions
Interventions
Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection
Placebo refers to a cell-free product, whose packaging, storage conditions, expiration date, and method of administration remain consistent with those of the investigational drug.
Human Umbilical Cord Mesenchymal Stem Cells Injection
the first phase (Phase Ia) is a single-dose administration
Human Umbilical Cord Mesenchymal Stem Cells Injection
the second phase (Phase Ib) is a multiple-dose administration.
Locations (1)
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China