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BioLogic-DT™ 与肝透析疗法传奇。

The BioLogic-DT™ and the saga of Liver Dialysis™.

机构信息

Indiana University Health Arnett, Lafayette, Indiana, USA.

HemoCleanse Technologies, LLC, Lafayette, Indiana, USA.

出版信息

Artif Organs. 2022 Apr;46(4):715-719. doi: 10.1111/aor.14211. Epub 2022 Feb 24.

DOI:10.1111/aor.14211
PMID:35211997
Abstract

Our small R&D company created a novel extracorporeal system for the treatment of hepatic coma and drug overdose, in which membrane motion in a screen-plate dialyzer served as a blood pump and also mixed dialysate containing powdered carbon. Early clinical trials of the Biologic-DT™ were successful in the treatment of patients with hepatic coma (especially from A-on-C liver failure) and FDA gave marketing approval. The BioLogic-DT™ was licensed to a venture capital-backed startup. It was marketed too widely and used in some patients without a chance for recovery or transplant. The licensing company failed, and the BioLogic-DT was not remarketed. The MARS™ device included albumin as a sorbent in dialysate, and clinical trials of this device also showed a benefit in the treatment of hepatic coma.

摘要

我们的小型研发公司开发了一种新型的体外系统,用于治疗肝昏迷和药物过量,其中膜在筛板式透析器中的运动充当了血液泵,并且还混合了含有粉末状碳的透析液。Biologic-DT™ 的早期临床试验成功地治疗了肝昏迷患者(特别是来自 A-on-C 肝衰竭的患者),并且 FDA 给予了营销批准。Biologic-DT™ 被授权给一家风险投资支持的初创公司。它的市场推广过于广泛,并且在一些没有康复或移植机会的患者中使用。授权公司失败了,Biologic-DT 没有重新上市。MARS™ 设备在透析液中包含白蛋白作为吸附剂,该设备的临床试验也表明在治疗肝昏迷方面有好处。

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