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Multiple‐unit and second transfusions of red cells enzymatically converted from group B to group O: report on the end of phase 1 trials
Author(s) -
Lenny L.L.,
Hurst R.,
Zhu A.,
Goldstein J.,
Galbraith R.A.
Publication year - 1995
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1046/j.1537-2995.1995.351196110892.x
Subject(s) - group b , group (periodic table) , group a , medicine , chemistry , surgery , organic chemistry
BACKGROUND : It has previously been shown that 1 and 2 units (200 – 400 mL) of red cells (RBCs) enzymatically converted from group B to group O by treatment with alpha‐galactosidase (ECO RBCs) are safe and efficacious when transfused to normal group O or A persons. STUDY DESIGN AND METHODS : The current report describes studies in which 1) normal group A and O subjects received large volumes of these cells (3 units), 2) some group O subjects underwent transfusion several months later, and 3) ECO RBCs were prepared by the use of recombinant coffee bean alpha‐galactosidase and transfused to a group O subject, to demonstrate the in vivo equivalence of ECO RBCs, whether prepared with native or recombinant alpha‐galactosidase. RESULTS : Clinical evaluation (hematologic tests, chemistry analysis, urinalysis) and serologic analyses did not reveal any evidence of subtle or acute transfusion reaction or significant increase in preexisting anti‐B titer. ECO RBC survival within the circulation of the recipients was normal (24‐hour survival, 95.5 +/− 0.9%; t1/2, 34.7 +/− 6.1 days; n = 8 transfusions), and the efficacy of the transfusions was manifested in elevations in recipient hemoglobin and hematocrit (hemoglobin increase, 1.5 +/− 0.6 g/dL; hematocrit increase, 3.6 +/− 1.6%; n = 8 transfusions). CONCLUSION : ECO RBCs are safe and efficacious when transfused more than once or in multiple‐unit volumes to group O or A subjects, and ECO RBCs prepared with recombinant or native enzyme are equivalent in vivo.