Thanh G Phan, Rebecca Lim, Siow T Chan, Hannah McDonald, Poh-Yi Gan, Shenpeng R Zhang, Liz J Barreto Arce, Jason Vuong, Tharani Thirugnanachandran, Benjamin Clissold, John Ly, Shaloo Singhal, Marie Veronic Hervet, Hyun Ah Kim, Grant R Drummond, Euan M Wallace, Henry Ma, Christopher G Sobey
BACKGROUND: We proposed a Phase I dose escalation trial to assess the safety of allogeneic human amniotic epithelial cells (hAECs) in stroke patients with a view to informing the design for a Phase II trial. METHODS: The design is based on 3 + 3 dose escalation design with additional components for measuring MR signal of efficacy as well as the effect of hAECs (2-8 × 106 /kg, i.v.) on preventing immunosuppression after stroke. RESULTS: Eight patients (six males) were recruited within 24 h of ischemic stroke onset and were infused with hAECs...
2023: Frontiers in Neuroscience