Safety observations in Phase I clinical evaluation of the Excorp Medical Bioartificial Liver Support System after the first four patients

A Phase I clinical safety evaluation of the Excorp Medical, Inc, Bioartific ial Liver Support System (BLSS) is in progress. Inclusion criteria are pati ents with acute liver failure of any etiology, presenting with encephalopat hy deteriorating beyond Parson's Grade 2. The BLSS consists of a blood pump , heat exchanger to control blood temperature, oxygenator to control oxygen ation and pH, bioreactor, and associated pressure and flow alarm systems. P atient liver support is provided by 70-100 g of porcine liver cells housed in the hollow fiber bioreactor. A single support period evaluation consists of 12 hour extracorporeal perfusion with the BLSS sandwiched between 12 ho urs of pre (baseline) and 12 hours of post support monitoring. Blood chemis tries and hematologies are obtained every 6 hours during monitoring periods and every 4 hours during perfusion. Physiologic parameters are monitored c ontinuously. The patient may receive a second treatment at the discretion o f the clinical physician. Preliminary evaluation of safety considerations a fter enrollment of the first four patients (F, 41, acetaminophen induced, t wo support periods; M, 50, Wilson's disease, one support period; F, 53, acu te alcoholic hepatitis, two support periods; F, 24, chemotherapy induced, o ne support period) is presented. All patients tolerated the extracorporeal perfusion well. All patients presented with hypoglycemia at the start of pe rfusion, treatable by IV dextrose. Transient hypotension at the start of pe rfusion responded to an IV fluid bolus. Only the second patient required he parin anticoagulation. No serious or unexpected adverse events were noted. Moderate biochemical response to support was noted in all patients. Complet ion of the Phase I safety evaluation is required to fully characterize the safety of the BLSS.