Human BioSystems, FDA to discuss platelet human infusion testing

By Elaine Rigoli

Tampa, Fla., Sept. 12 - Human BioSystems, Inc. has scheduled a pre-Investigational New Drug application meeting with the Food and Drug Administration for early October to discuss the company's plan to conduct human infusion tests using its patented platelet preservation system.

The meeting is a prelude to a formal application to proceed with human testing once all concerns and requirements of the FDA are satisfied. The planned studies will involve a number of human subjects that are infused with platelets stored in the cold using the company's process and compared to platelets prepared using the current storage method.

The company said the platelets are uniquely labeled prior to infusion to distinguish the Human BioSystems platelets from the control group and monitored for platelet survival in the bloodstream over time.

Human BioSystems develops preservation platforms for organs and other biomaterials and is based in Palo Alto, Calif.

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