A Phase I/IIa Clinical Trial on the Safety, Tolerability, and Preliminary Efficacy of Human Placental-Derived 3D Mesenchymal Stem Cell Injection Administered Via the Intravenous Route in Patients With Acute Ischemic Stroke (AIS): A Randomized, Double-Blind, Placebo-Controlled Study
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).
• Age ≥18 years and ≤80 years; any gender
• Body weight 45-90 kg
• Diagnosed with acute ischemic stroke, with onset between 6 and 72 hours (inclusive) prior to enrollment; received thrombolysis or not planned for thrombolysis and no planned thrombectomy
• NIHSS score 6-20, with NIHSS item 1a (Level of Consciousness) \<2
• Participant or legally authorized representative able to understand and provide written informed consent