Human Placenta-derived 3D Mesenchymal Stem Cells(Guojianqingke)

Summary

This is a Phase I/IIa clinical trial evaluating human placental-derived 3D mesenchymal stem cell (MSC) injection in patients with acute ischemic stroke (AIS). Phase I is a single-dose escalation study to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Phase IIa explores preliminary efficacy. Each participant undergoes screening (up to 72 hours before treatment), a single-day treatment period, and follow-up for up to 720 days (24 months).

Timeline

Start

2026-06-01

Primary completion

2027-12-30

Completion

2028-12

Drugs

Indications