Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
This study is a two strata, dose escalation Phase I clinical trial designed to assess the
safety and determine the maximal tolerated dose (MTD) of allogenic cord tissue derived MSCs
(cMSCs, stratum 1) and allogeneic, interferon-γ primed bone marrow MSCs (γMSCs, stratum 2).
Each stratum is designed to independently accrue 3 children at a dose level 1 of 2x106
cells/kg and 6 children at dose level 2 of 10x106 cells/kg, resulting in 9 children in each
stratum. The primary objectives are to determine the safety and toxicity of allogeneic cord
tissue derived MSCs and allogeneic interferon-γ primed bone marrow derived MSCs.