相关临床试验
6
0 进行中
药物批准
0
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监管机构
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成立时间
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已完成
4
66.7%
撤回
2
33.3%
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- United Therapeutics announced positive results from the world's first FDA-cleared clinical trial using a bioengineered liver device, miroliverELAP, for treating acute liver failure patients. - The Phase 1 study successfully met its primary safety endpoint in five patients who were not transplant candidates, with continuous treatment for at least 44 hours and no unexpected serious adverse events. - Approximately 30% of acute liver failure patients die due to transplant ineligibility or organ unavailability, highlighting the critical need for alternative treatments like miroliverELAP. - Based on these positive results, United Therapeutics plans to initiate a Phase 2 study to further evaluate this innovative bioengineered organ alternative technology.
- United Therapeutics and Intermountain Health successfully treated the world's first patient with miroliverELAP, a bioengineered external liver assist device, marking the first human clinical trial of a manufactured organ alternative. - The procedure was performed on an acute liver failure patient ineligible for transplant at Intermountain Medical Center, using a device that combines a decellularized porcine liver scaffold with human endothelial and liver cells. - Approximately 30% of acute liver failure patients die without access to liver transplant, with about 86,000 patients hospitalized annually in the U.S. with acute forms of liver failure. - The phase 1 study, initiated in 2024, is currently enrolling patients with acute liver failure at eight sites across the United States.
