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

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).

NCT Number	NCT07635758
Lead Sponsor	Chinese PLA General Hospital
Conditions	Acute Ischemic Stroke
Enrollment	24 participants
Start Date	2026-06-01
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-09