Hemocellular receives Research Award from Center

BT Catalyst,  May, 2003  

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Hemocellular Development Corp. of Durham has received a $149,654 Small Business Research Award from the North Carolina Biotechnology Center for the "Safety Evaluation of Lyophilized Platelets."

The development of rehydratable, lyopilized platelets (RLPs) is an innovative advance in transfusion medicine. Investigators at East Carolina University in Greenville and the University of North Carolina at Chapel Hill have characterized the properties of the lyophilized cells and provided preliminary data in animal-model systems that RLPs are highly effective for controlling hemorrhage.

The goal of the proposed studies is to estimate the range of RLP doses that are safe for human Phase I trials. Dogs will be infused bimonthly in a dose-escalation paradigm, and then pathophysiological responses of the animals to the infusions will be monitored during the hours and days after each infusion. After the last infusion the subjects will receive a detailed histological analysis for microthrombi and other potential adverse events.

The results of these studies will be used to plan phase I human trials in the context of an investigative new drug (IND) application to the FDA.

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