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How Do You Stop Multi-Organ Failure in Shock Patients?

Bioengineering research from the Jacobs School is at the center of a 200-patient Phase 2 clinical pilot study now under way. The trial is testing the efficacy and safety of a new use and method of administering an enzyme inhibitor to stop multi-organ failure in shock patients.

This new use of an FDA-approved drug is based on decades of research by bioengineering professor Geert Schmid-Schönbein on the microvascular and cellular reactions that lead to multiorgan failure after a patient has gone into shock, which is the second-leading cause of in-hospital deaths in the United States.

(L-R) Bioengineering professor Geert Schmid-Schönbein, InflammaGen Therapeutics Chief Executive Officer John Rodenrys, InflammaGen Therapeutics President Hank Loy, and Dr. Erik Kistler, assistant clinical professor in the Department of Anesthesiology and Critical Care at the UC San Diego School of Medicine and the VA San Diego Healthcare System and Jacobs School alumnus in bioengineering (M.S. '94, Ph.D. '98).

Schmid-Schönbein and his colleagues discovered that under conditions of shock, the epithelial cell barrier that lines the small intestine becomes permeable causing potent digestive enzymes to be carried into the wall of the intestine, bloodstream and lymphatic system where they digest and destroy healthy tissue, a process he named autodigestion. His method of blocking the enzymes with an enzyme inhibitor was licensed to InflammaGen Therapeutics in 2005. The company has since developed the InflammaGen Shok-Pak, a drug/delivery platform that delivers the drug through a nasogastric tube directly into the stomach and lumen of the intestine.

“We are testing for the first time whether it is possible to help severely ill patients by blocking autodigestion, a condition in which digestive enzymes not only break down food inside the intestine but also the intestine itself,” Schmid-Schönbein said. “We have pre-clinical results that this treatment can save lives.”

Dr. Erik Kistler, the study's principal investigator and a Jacobs School bioengineering alumnus (M.S. '94, Ph.D. '98), believes the treatment protocol might also improve patients' long-term outcomes and reduce the time patients spend in intensive care.

InflammaGen Shok-Pak has been used successfully outside the United States as a rescue therapy in 15 patients, most of whom were diagnosed with life-threatening conditions. Preclinical studies of the technology in two animal species have demonstrated significant increases in long-term survival.

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