A Novel Homograft Heart Valve Preservation Process

一种新颖的同种移植心脏瓣膜保存工艺

• 批准号: 6550533
• 负责人: DAVID T. CHEUNG
• 金额: $ 16.34万
• 依托单位: PHILOGENESIS, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-01 至 2003-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6550533
• 关键词: antiseptic sterilization; collagen; cryopreservation; cryoprotective agents; gas; heart preservation; heart valve transplantation; homologous transplantation; lyophilization; sheep; technology /technique development; tissue engineering; transmission electron microscopy

DESCRIPTION (provided by applicant): Approximately 60,000 heart valve replacement surgeries are performed each year in the U. S. alone with nearly 4,500 of these being allograft tissue valves. Current available technology for procurement of allografts involves the use of antibiotic storage solutions and cryopreservation techniques. These methods require the added complication and expense of specialized storage and transport systems. We have developed a process referred to as D-Hydro(TM) technology for the treatment, lyophylization and sterilization of allograft valve tissue. Preliminary studies in sheep indicate that this treatment provides a nonimmunogcnic, intact collagen tissue matrix that becomes a "living tissue" allograft through host cell rehabitation. We will evaluate-processed homografts for competency in the orthotopic position, induction of host immune response, and validation of the sterilization process and effect of sterilization on tissue integrity. Since the process does not require that harvested homografts contain viable cells, extension of tissue procurement time will be studied. Our plan is to commercialize this process and implement it through existing valve banks in the U. S. as well as other parts of the world should the proposed studies support our preliminary observations. PROPOSED COMMERCIAL APPLICATION: The goal of Philogenesis, Inc. is to license the D-Hydro(TM) technology to an organization that procures, processes and distributes donor tissues such as the Red Cross and possibly to companies currently involved in cryopreservation of homograft valves. If the process proves successful in human clinical trials it will be expanded to include other tissue sources.

描述（由申请人提供）：美国每年进行约60，000例心脏瓣膜置换手术。S.其中有将近4,500个是同种异体组织瓣膜。目前可用于同种异体移植物获取的技术包括使用抗生素储存溶液和冷冻保存技术。这些方法需要增加专门的储存和运输系统的复杂性和费用。我们开发了一种称为D-Hydro（TM）技术的工艺，用于同种异体瓣膜组织的处理、冻干和灭菌。在绵羊中的初步研究表明，这种治疗提供了一种非免疫原性的、完整的胶原组织基质，通过宿主细胞的再结合成为一种“活组织”同种异体移植物。我们将评估处理后的同种移植物在原位的能力、诱导宿主免疫反应以及验证灭菌过程和灭菌对组织完整性的影响。由于该过程不要求收获的同种移植物含有活细胞，因此将研究组织获取时间的延长。我们的计划是商业化这一进程，并通过现有的阀门银行在美国实施。S.以及世界其他地区，如果拟议的研究支持我们的初步观察。 拟议的商业应用：Philogenesis，Inc.的目标。是将D-Hydro（TM）技术许可给一个采购、处理和分发供体组织的组织，如红十字会，并可能许可给目前参与同种移植瓣膜冷冻保存的公司。 如果这一过程在人体临床试验中证明是成功的，它将扩大到包括其他组织来源。