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NOT YET RECRUITING
NCT07628933
PHASE1

A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke

Sponsor: BOE Technology Group Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Human Umbilical Cord Mesenchymal Stem Cells Injection

the first phase (Phase Ia) is a single-dose administration

DRUG

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