Erythromer (EM), a Nanoscale Bio-Synthetic Artificial Red Cell

In pre-hospital, austere military and other resource limited settings where stored blood products are frequently unavailable, undesirable, or in short supply, there is a critical need for a transportable, temperature-stable blood substitute, containing an artificial oxygen (O2) carrier, to treat life-threatening blod loss. To address this need, we have developed ErythroMer (EM), a first-in-class, bio-synthetic, nano-cyte blood substitute. EM is a deformable, hybrid peptidic-lipid nanoparticle that incorporates high per particle payloads of hemoglobin (Hb) in a fashion that both (a) confers context-responsive control of O2 capture and release and (b) limits adverse reaction between Hb and nitric oxide (NO). The EM ‘artificial cell’ bio-inspired design has yielded a prototype that fully emulates key RBC physiology and represents a potentially disruptive introduction into Transfusion Medicine. The EM lead prototype has passed rigorous initial “proof of concept” testing (in vitro and in vivo), that affirms that this design surmounts prior challenges in emulating normal RBC physiologic interactions with O2 and NO. In models of major bleeding/anemia, EM reconstitutes normal hemodynamics and O2 delivery, observed at the system, tissue, and cellular level. EM potential for extended ambient dry storage has significant implications for portability and use. Next steps include formulation scaling, detailed study of pharmacokinetics, biodistribution and safety, as well as evaluation in large animal models of hemorrhagic shock.