Limitations of the study
This study has a few limitations. First, the limitations of this trial are related to the design features of a phase I trial, namely the relatively small number of subjects in each cohort that may limit generalizability. The study did not include elderly subjects, the majority of the subjects were younger than 40 years. Second, there was significant loss of biological material of the lowest dose group (0.005 mL/kg MRG-001) because of shipping delays caused by a winter storm in Texas. This made it impossible to analyze flow cytometric and some of the RNA sequencing outcomes of this group, limiting our ability to draw a definitive conclusion on the pharmacodynamics of the lowest dose group.