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Biotech / Medical : SANGUINE CORP. (SGNC) -- Ignore unavailable to you. Want to Upgrade?

To: Profiteer who wrote (2173)	6/30/1998 1:59:00 PM
From: Profiteer	Read Replies (1) \| Respond to of 5402

SOMETHING TO READ, from the FDA site during this slow period! **************** For the Future A look to the future may envision the ultimate alternative to homologous transfusion to be artificial blood. As blood is extremely complex, however, the dream of a true substitute may never berealized. Even so, one important blood function has been reproduced artificially: bloodstream transport of life-giving oxygen, the substance all tissues need to survive. The ideal artificial blood oxygen carrier would pick up oxygen in the lungs and deliver it to all tissues, have a long shelf life with stability at room temperature, be compatible with all blood types, and present no risk of infection, immune reaction, or other health problem. In 1989, FDA licensed the first artificial oxygen carrier, Fluosol, which used substances called "perfluorochemicals" to temporarily transport oxygen to the heart during coronary artery balloon angioplasty. But the product carried limited amounts of oxygen and had other drawbacks. The manufacturer recently stoppedproduction. Fratantoni says that two new investigational perfluorochemicals have advantages over Fluosol, including greater oxygen solubility and the capability to be stored at room temperature without being reconstituted before infusion. Researchers are also experimenting with modifying normal red blood cells so that the cells can be freeze-dried, stored at room temperature, and then reconstituted and infused without concern forblood type. One modification, by a process called "polymerization," permits high concentration and increases circulation time. Using another technique that encapsulates red cells with a fatty membrane, researchers have supported oxygen requirements in animals with too few red cells to sustain life. But a major problem with perfluorochemical and red cell oxygen carriers is that the bloodstream retains them only six to 36 hours. Normal red cells survive 100 to 120 days. There also is an ethical consideration to testing artificial oxygen carriers in human studies in which some participants would get the real biologic while others receive a placebo (dummy)infusion. According to Thomas Zuck, M.D., director and professor of Hoxworth Blood Center of the University of Cincinnati Medical Center, in Transfusion Medicine in the 1990's: "If whole blood or red cells that are known to be effective are available, it would be difficult to contend that participating in blood> <substitute clinical trials for acute hemorrhage would benefit recipients." At a meeting in March 1990, members of FDA's Blood Products Advisory Committee expressed concerns about reports of severe, unexplained toxicity of artificial red cell oxygen carriers in patients in clinical trials. Fratantoni and other CBER experts evaluated the committee's recommendations, as well as animal and human studies of the preparations. In the May 1991 issue of Transfusion, FDA published "points to consider" for researchers investigating red cell oxygen carriers. In evaluating risks and benefits of the carriers, the agency recommended "consideration of, and comparison with, the safety profile of approved oxygen carriers, such as red cells [derived from the public blood supply]." No one knows for sure whether researchers will ever develop an "ideal" artificial oxygen carrier as an alternative to homologous transfusion. But promising possibilities are on the drawing board, and FDA is monitoring those possibilities.