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异种移植治疗1型糖尿病研究迈进临床阶段

2017-09-09 20:01:40   央广网

央广网长沙9月9日消息(记者傅蕾 通讯员蒋凯)9月8日上午,中南大学湘雅三医院发布王维教授团队研究的“‘新生猪’胰岛移植治疗1型糖尿病小样本临床研究”专家评审结果。专家组建议将异种胰岛移植治疗糖尿病技术纳入三类医疗技术管理并制定相应临床应用技术规范,推动该技术的临床应用。

从2008年异种胰岛移植临床研究的长沙宣言,到今天发布的异种胰岛移植临床治疗的长沙方案,湘雅三医院王维教授领衔团队经历了10年的沉淀,从1996年开始,研究团队坐了21年冷板凳。

9月8日上午,评价专家组详细审阅了项目材料,认真听取了项目组汇报,并就相关问题进行了质询。专家组认为,该项目临床研究过程严谨,技术资料齐全完整,并符合规定,结果可靠。经审查评议,专家组一致认为:项目团队历经二十年持之以恒的研究,在国际上首次建立了移植供体培养-猪胰岛提取-临床应用的完整技术体系,具有可靠的生物安全性,取得了目前国际上异种胰岛移植的最佳疗效,可以应用于1型糖尿病的治疗,达到国际领先水平。

据悉,全球糖尿病患者高达数亿,为了攻克治疗糖尿病这一世界性的难题,各国专家都进行了大量研究,公认胰岛移植是安全有效的治疗方法,临床证明从移植人体的胰岛细胞到患者体内效果明显。然而人源性器官供体极端匮乏,能够得到同体(即人体)胰岛移植的数量极为有限,能被拯救的患者人数少之又少。

为了突破胰岛移植供体匮乏的“瓶颈”,让千百万患者能够得到有效治疗。中南大学湘雅三医院王维教授团队选择移植猪胰岛尝试,经过近21年努力,逐步取得多方面的突破。2013年启动并于今天通过专家鉴定的“‘新生猪’胰岛移植治疗1型糖尿病小样本临床研究”获得成功,为大规模移植猪胰岛开辟了广阔道路。王维教授介绍:“从现在开始,我们与国内医院合作,已具备收治糖尿病患者的能力,通过两年的努力,力争达到每年让万名以上糖尿病患者脱离苦海的目的。”

广大患者最关心的是从移植猪胰岛跟移植人体胰岛相比,疗效如何?王维教授介绍说:“基本达到与移植人体胰岛的相似效果,也就是说基本疗效一样,当然我们还在努力工作进一步提升治疗效果,争取达到治愈糖尿病的治疗效果”。

“‘新生猪’胰岛移植治疗1型糖尿病小样本临床研究”中,移植用的猪胰岛,是从湖南赛诺生物科技股份有限公司提供的供体猪身上提取的。这家公司和湘雅三医院经过大量筛选,选出最适合用于移植的品种猪,兴建了世界第二、亚洲第一的生物安全供体猪培育中心,将选用猪在这座“五星级猪宾馆”进行饲养。在饲养过程中,特别注重对供体猪质量进行优化,不仅保证了猪的各种器官、血管的健康,排除了国际异种移植协会规定的导致人畜共患疾病的病原体,也就是避免将猪的任何疾病传染到被移植患者身上,达到了世界卫生组织规定的生物安全标准的医用级猪的标准。这一创新技术保证了猪胰岛移植的生物安全性,克服了人胰岛难以避免携带病原体和自身免疫攻击的缺陷,为猪胰岛移植治疗糖尿病临床研究奠定了基础。

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