Safety Study of ECO Conversion System For Red Blood Cells.
NCT00261274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2020-05-27
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
A-ECO
- BIOLOGICAL
-
Saline
Sponsors & Collaborators
-
Velico Medical
lead INDUSTRY
Principal Investigators
-
Kurt Gunter, MD · ZymeQuest, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-11-30
- Primary Completion
- 2009-01-31
Countries
- United States
Study Locations
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