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

NCT07628933 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-06-05

No results posted yet for this study

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.

Conditions

  • Acute Ischemic Stroke
  • AIS

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.

Sponsors & Collaborators

  • BOE Technology Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-03-30
Completion
2029-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628933 on ClinicalTrials.gov