Liposome-Encapsulated Hemoglobin, TRM-645: Current Status of the Development and Important Issues for Clinical Application.
Clinical application of artificial oxygen carriers as a substitute for blood transfusion has long been expected to solve some of the problems associated with blood transfusion. Use for oxygen delivery treatment for ischemic disease by oxygen delivery has also been examined. These prospective applications of artificial oxygen carriers are, however, still in development. We have developed liposome-encapsulated hemoglobin (LEH), developmental code TRM-645, using technologies for encapsulation of concentrated hemoglobin (Hb) with high encapsulation efficiency as well as surface modification to achieve stability in circulating blood and a long shelf life. We have confirmed the basic efficacy and safety of TRM-645 as a red blood cell substitute in studies on the efficacy of oxygen delivery in vivo, and the safety of TRM-645 has been studied in some animal species. We are now examining various issues related to clinical studies, including further preclinical studies, management of manufacturing and the quality assurance for the Hb solution and liposome preparations manufactured by the GMP facility.
Kaneda
Shinichi
S
Terumo Corporation, Research and Development Center, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan.
Ishizuka
Takanobu
T
Goto
Hiroshi
H
Kimura
Tetsuhiro
T
Inaba
Katsutoshi
K
Kasukawa
Hiroaki
H
D000818:Animals; D001802:Blood Substitutes / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology*; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D004355:Drug Stability; D006801:Humans; D008081:Liposomes; D010100:Oxygen / Q000378:metabolism
D001802:Blood Substitutes; D008081:Liposomes; D010100:Oxygen