Clinical Center Reference Endotoxin

Clinical Center Reference Endotoxin (CCRE) is a standardized preparation of bacterial endotoxin derived from Escherichia coli O:113. It was developed as a replacement for the earlier EC-5 lot to serve as a reference standard in human experimental models of systemic inflammation and innate immune activation. CCRE is used primarily in clinical research to induce controlled inflammatory responses in healthy volunteers or patients, enabling the study of cytokine release, leukocyte dynamics, fever response, and other aspects of human immunology. The mechanism involves activation of innate immune pathways via Toll-like receptor 4 (TLR4), leading to robust production of pro-inflammatory cytokines such as TNF-alpha, IL-6, and IL-8. The product has been manufactured under GMP conditions by List Biologicals Laboratories at the request of the NIH after regulatory requirements changed[1][2][6]. Its use is restricted to research settings; it is not intended for therapeutic purposes.

Brand names

Clinical Center Reference Endotoxin

Other names

CCREEscherichia coli O:113 endotoxin (Clinical Center lot)NIH reference endotoxin