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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261274
|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.|