Table 1 Red cell substitutes under active (phase III) investigation
Company | Product | Type | Clinical trial status |
|---|---|---|---|
Northfield Laboratories | PolyHeme® | Human glutaraldehyde polymerized | Ongoing phase III multicenter trials in North America in vascular and general surgery. Initiating phase III DOD trial in trauma to begin in the prehospital setting |
Biopure | Hemopure®: hemoglobin glutamer-bovine | Bovine glutaraldehyde polymerized | Completed phase III multicenter trial USA orthopedic surgery. Biologic license application under review by US Food and Drug Administration. Approved for use in South Africa. Initiating phase III DOD trial in trauma to begin in the prehospital and emergency center settings |
Hemosol Inc. | HemoLinkâ„¢: hemoglobin raffimer | Human O-raffinose polymerized | Completed phase III multicenter trial in coronary bypass patients in Canada and the UK. Planning anemia trials in North America |