Ex vivo methods for validating substance testing with human organs and/or tissues
AssigneeLifeline Scientific, Inc.
InventorsChristopher Gerald Curtis, John Brassil, David Kravitz
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Abstract
Methods of validating results of assessments of test substances using human-derived tissues and/or organs, particularly tissues and/or organs unsuitable for transplantation, include assessing the suitability of the organ and/or tissue for substance testing, as well as inter-organ variability and use of exogenous and/or endogenous controls.
Claims48
A method of validating results of substance testing using at least one human organ or tissue selected from the group consisting of a metabolically active human organ or tissue that has been permanently removed from its origin and an engineered organ or tissue derived from isolated and/or cultured human cells, comprising:
- (a) assessing said human organ or tissue for suitability for testing prior to administration of a test substance;
- (b) perfusing said organ or tissue with a perfusate containing said test substance;
- (c) assessing a parameter relating to said test substance;
- and
- (d) assessing said organ or tissue for suitability for testing of said parameter relating to said test substance during and/or after administration of said test substance.
Dependencies are inferred from the claim text.