Safety evaluation of an artificial O2 carrier as a red blood cell substitute by blood biochemical tests and histopathology observations.
Recombinant human serum albumin (rHSA) incorporating synthetic heme with a covalently linked proximal base (albumin-heme [rHSA-hemel) is an artificial O2 carrier that can transport O2 like hemoglobin does in the blood stream. To evaluate the clinical safety of this compound, 20% and 40% exchange transfusions with rHSA-heme into anesthetized rats were followed by blood biochemical tests and histopathologic observations for 7 days. In the 20% rHSA-heme group, a total of 30 analytes by blood biochemical tests showed almost the same values as those observed in the reference 20% rHSA group. Although some abnormal values for liver parameters were found in the 40% rHSA-heme group, they returned to normal after 7 days. Histopathologic observations indicated that the administration of rHSA-heme in a volume of 20% total blood volume did not produce any negative side effects on the vital organs.
Huang
Yubin
Y
Advanced Research Institute for Science and Engineering, Waseda University, Shinjuku-ku, Tokyo, Japan.
Komatsu
Teruyuki
T
Yamamoto
Hisashi
H
Horinouchi
Hirohisa
H
Kobayashi
Koichi
K
Tsuchida
Eishun
E
D000818:Animals; D001774:Blood Chemical Analysis; D001802:Blood Substitutes / Q000009:adverse effects*; D005078:Exchange Transfusion, Whole Blood; D006418:Heme / Q000009:adverse effects* / Q000138:chemical synthesis; D006801:Humans; D007668:Kidney / Q000473:pathology; D008099:Liver / Q000473:pathology; D008297:Male; D051381:Rats; D017208:Rats, Wistar; D011994:Recombinant Proteins; D012449:Safety; D012709:Serum Albumin / Q000009:adverse effects*; D000075462:Serum Albumin, Human
D001802:Blood Substitutes; D011994:Recombinant Proteins; D012709:Serum Albumin; C501631:recombinant human serum albumin-heme; D006418:Heme; D000075462:Serum Albumin, Human