Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261274
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2005-11-30
Brief Title:
Safety Study of ECO Conversion System For Red Blood Cells
Sponsor:
Velico Medical
Organization:
Velico Medical
Study Overview
Official Title:
Evaluation of the Safety of Repeated Autologous Infusions of Enzyme-Converted A-to-O A-ECO Red Cells Into Group A Volunteers
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to demonstrate that small amounts of a persons 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
Detailed Description:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None