The purpose of this study is to demonstrate that small amounts of a person's own red cells, when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused, repeatedly. Each participant will have some blood drawn, treated with an enzyme, washed and re-infused five times. Additional samples of blood will be drawn for testing and evaluation.
This study will involve a statistically valid number of subjects so that firm conclusions may be drawn about the safety of small volumes of A-ECO cells. All participants will receive their own (autologous) red cells that have been either: 1) treated with an enzyme to create A-ECO cells (test group); or 2) washed with saline (control group). The test and control groups will be compared for the rate and extent any adverse reactions or unexpected laboratory test results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Minnesota
Minneapolis, Minnesota, United States
TriCore Reference Laboratories
Albuquerque, New Mexico, United States
Hoxworth Blood Center
Cincinnati, Ohio, United States
Adverse events, clinically significant bruising over a period of 10 weeks.
Unexpected lab test results over 10 weeks.
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American Red Cross Blood Services-Penn Jersey Region
Philadelphia, Pennsylvania, United States
American Red Cross
Norfolk, Virginia, United States