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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

同时,王维教授团队建立了国际领先的大规模高效猪胰岛分离纯化系统和检测系统,可以像流水生产线一样提取大批量的的猪胰岛,又保证了提取胰岛的纯度和活性。

王维教授团队在世界上首次建立猪胰岛移植治疗糖尿病临床技术体系,设计了能够保护移植胰岛的微创手术方案。目前国内外移植胰岛手术,都采取经皮肤和肝脏穿刺的方法,这种手术并发症多,还容易导肝内凝血,血凝块往往将移植进来的胰岛包住,使胰岛因缺氧而死亡。新的手术方案则是经颈静脉将胰岛移植到肝内,不仅可以减少并发症的出现,肝内凝血也基本不会发生,避免了出血凝块“吃”掉被移植进来胰岛现象的出现。

新的临床胰岛移植治疗方案在移植胰岛的同时,还回输了来自患者自身的调节性T细胞,它可使患者体内对移植胰岛的排斥反应明显减轻,大大降低了术后抗排斥药的使用剂量。跟人胰岛移植术相比,术后抗排斥药物的使用量明显减少,抗排斥药产生的毒副作用也相对较小。临床结果说明这一创新的移植技术体系具有高度安全性和有效性。

在此基础上,王维教授团队完成了对10名1型糖尿病患者进行猪胰岛移植研究。这些患者的病情都非常严重,多数已生活无法自理。移植猪胰岛后病情明显好转,血糖稳定正常,糖化血红蛋白也恢复正常,跟术前比较,总体胰岛素使用减少60%以上,最好效果减量90%。根据国际共认的胰岛称植综合评分,平均达到0.62分,最好达到0.88分(完全治愈糖尿病为1分),远远高于日本最高0.17分的疗效。

专家认为:“‘新生猪’胰岛移植治疗1型糖尿病小样本临床研究”项目技术已达到世界领先水平,其成果具有5个全球首创:第一、在免疫排斥调控领域处于国际领先水平。第二、在移植供体猪种系筛选方面项目走在国际同行的前列,培育了具有我国自主知识产权的无病毒DPF猪(赛诺猪)。第三、全球首次在临床上使用生物安全无病毒赛诺猪作为移植供体,证明了我国自主培养的供体猪可以保证猪胰岛移植的生物安全性;第四、在异种胰岛移植临床研究上取得国际领域中最好的疗效。在安全性、有效性和可靠性上,创世界最好记录。第五、形成了从供体猪培育体系到胰岛分离纯化技术体系到临床治疗技术体系的全系统原始创新成果,推动了国际及我国异种胰岛移植行业的发展。

附:中南大学湘雅三医院团队的研究经过七个重要的发展阶段

王维教授联合易受南教授、莫朝晖教授组织科研团队开展猪胰岛研究,先后在七个阶段处于国际领先地位,人称兴建了一座“七级浮屠”。

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