Thirteen Participants Treated in ACT’s Stem Cell Clinical Trial
Nov. 15, 2012 – Results from the first-ever clinical trials of a retinal disease treatment derived from stem cells continue to be encouraging. Advanced Cell Technology (ACT), developer of the therapy, recently reported that 13 people — nine with Stargardt disease and four with dry age-related macular degeneration (AMD) — have had no safety issues after receiving transplanted cells. In addition, modest vision improvements for the first participants treated more than a year ago have been sustained.
According to ACT, the transplanted cells — retinal pigment epithelial (RPE) cells developed from human embryonic stem cells — appear to be engrafting into the retinas of some of the participants. Engraftment is an indicator that the transplanted cells have the potential to function like native cells.
RPE cells provide essential nutrition and waste removal for photoreceptors, the cells that provide vision. The dysfunction of RPE cells in dry AMD and Stargardt disease eventually leads to loss of photoreceptors.
The first nine participants in ACT’s trials each received transplants of 50,000 cells, and the next four received 100,000 cells. The researchers plan to transplant as many as 200,000 cells for the treated retina of each patient during their three Phase I/II clinical trials. Two studies — one for dry AMD, the other for Stargardt disease — are taking place in the United States. A trial for Stargardt disease is also underway in the United Kingdom.
ACT’s researchers plan to treat people with less advanced disease in later stages of their human studies. They believe the treatment may provide greater vision improvement in these individuals.
The Foundation Fighting Blindness funded laboratory research that made ACT’s human studies possible.
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13个参加ACT的干细胞临床试验治疗
11月15日，2012 -有史以来第一次来自干细胞治疗视网膜疾病的临床试验的结果是令人鼓舞的。先进细胞技术（ACT），开发人员的治疗，最近有报道，有13人-九Stargardt病干年龄相关性黄斑变性（AMD）和4 -有没有安全问题后，接受移植的细胞。此外，适度的首批参与者的
视力改善处理较一年前一直持续下去。据ACT，移植的细胞-视网膜色素上皮细胞（RPE）细胞从人类胚胎干细胞-似乎被嫁接到视网膜一些与会者。视网膜色素上皮细胞的植入是一个指标，移植的细胞有可能像天然细胞的功能。提供必要的营养和废物清除感光器，提供视觉细胞。干性AMD和Stargardt病的视网膜色素上皮细胞的功能障碍，最终导致光感受器的损失。第一位受测者在ACT的试验，收到的50,000个细胞的移植，并在未来四年获得10个。研究人员在他们的三个阶段I / II期临床试验，计划每个病人的治疗视网膜细胞移植多达20万。两项研究- 干性AMD，Stargardt病 -发生在美国。在英国Stargardt病的试验也正在进行中。ACT的研究人员计划以诚待人，配不到先进的疾病在人类研究的后期阶段。他们认为治疗可以改善这些人提供更大的视野。基金会战斗失明资助的实验室研究，提出了ACT的人的研究成为可能。 |
