Approach to clinical trial considering medical ethics and efficacy for HbV, liposome encapsulated hemoglobin vesicle.

Since around 1985, a liposome encapsulated hemoglobin vesicle (HbV) has been developed in Waseda University as an artificial red cell. Subsequently, in 1995, Terumo Co. produced a prototype of HbV for clinical trial, the so-called Neo Red Cell. We tested this in preclinical study and believed firmly that infusion of the HbV could substitute for ordinary blood transfucion. Subsequently, further improvement was done on the HbV by investigators of Waseda and Keio University supported by a grant of Health & Welfare Ministry, Japan, and recent physicochemical properties of the HbV are evaluated, mostly applicable for clinical trial.