Safety Study of ECO Conversion System For Red Blood Cells.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Evaluation of the Safety of Repeated Autologous Infusions of Enzyme-Converted A-to-O (A-ECO) Red Cells Into Group A Volunteers.|
- Adverse events, clinically significant bruising over a period of 10 weeks.
- Unexpected lab test results over 10 weeks.
|Study Start Date:||November 2005|
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.
|United States, Connecticut|
|Yale New Haven Hospital|
|New Haven, Connecticut, United States, 06510-3202|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, New Mexico|
|TriCore Reference Laboratories|
|Albuquerque, New Mexico, United States, 87102|
|United States, Ohio|
|Hoxworth Blood Center|
|Cincinnati, Ohio, United States, 45267-0055|
|United States, Pennsylvania|
|American Red Cross Blood Services-Penn Jersey Region|
|Philadelphia, Pennsylvania, United States, 19123|
|United States, Virginia|
|American Red Cross|
|Norfolk, Virginia, United States, 23507|
|Study Director:||Kurt Gunter, MD||ZymeQuest, Inc.|