美國最高衛生機關-食品藥物管理局(FDA)於1月3日公佈第三例核准的胚胎幹細胞人體臨床試驗.該試驗也是由通過第二例的先進生物科技公司(Advanced cell techology;ACT)所執行,針對乾性老年性黃斑病變(Dry Age-Related Macular Degeneration;Dry AMD)的病人進行試驗.
ACT在2010年11月通過FDA核准為12名患有先天性眼底黃斑變性症(Stargardt's macular degeneration)的病人進行胚胎幹細胞的治療.科學家將胚胎幹細胞於體外分化成視網膜上皮細胞(Retinal Pigment Epithelium;RPE),注射數萬顆此細胞於病患眼睛中.
ACT於11月30日再度向FDA的新藥試驗(IND)提出申請,利用相同的RPE細胞治療乾性老年性黃斑病變.預計募集12名病患進行第一和第二期的臨床試驗,首要目標如同第二例試驗,先進行胚胎幹細胞移植的安全評估.
估計全世界目前有三千萬的人罹患AMD,其中美國就占有一半的病人.AMD發病年齡主要在65-85歲,因老化使得黃斑的視網膜感光細胞退化,影響視力.目前無治療方法,因此這次的胚胎幹細胞試驗將會是一個最新的治療方法.
FDA approves third human stem cell trial
A therapy derived from human embryonic stem cells may help millions of Americans battle a common form of blindness.
Advanced Cell Technology (ACT), which in November won approval to use hES cells to treat a rare form of juvenile blindness called Stargardt's disease, announced on January 3 that it had the go-ahead to use the cells in a trial of adults with a related but far more common condition: age-related macular degeneration (AMD).
Advanced Cell Technology Inc. said Monday that it has received a green light from the U.S. Food and Drug Administration to begin a clinical trial to test its therapeutic cells as a treatment for dry age-related macular degeneration. The company plans to enroll a dozen patients in a Phase I/II trial, which would primarily test the safety of the cells and whether they are well-tolerated by patients.
Age-related macular degeneration is a disease in which the macula – in the middle of the retina in the back of the eye – is gradually destroyed. In the dry version of AMD, objects in the center of a patient’s visual field become blurry and they have trouble recognizing faces, according to this explainer from the National Eye Institute. Though there are treatments that may stall the progression of dry AMD, there is no cure. An estimated 10 million to 15 million Americans suffer from dry AMD, and that number is expected to rise as the population ages.
http://articles.latimes.com/2011/jan/03/news/la-heb-stem-cells-for-macular-degeneration-20100103
