FDA批准UCLA的IND申请，进行胚胎干细胞的严重近视眼临床试验

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美国FDA日前批准了由UCLA和ACT合作进行的人胚胎干细胞治疗严重近视的新药临床申请。此项研究将采用人胚胎干细胞来源的视网膜色素上皮细胞RPE进行12例为期1年的临床试验，目的是检验治疗的安全性和耐受性。( B' n+ F/ k7 z! }

+ P: d0 @! X1 g& H5 u- K3 \0 }FDA approves UCLA IND application to commence embryonic stem cell-based trial
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Published 12 February 2013
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The USFDA has approved the investigator investigational new drug (IND) application of University of California, Los Angeles (UCLA), the clinical partner of Advanced Cell Technology (ACT), to commence a clinical trial using the human embryonic stem cells (hESCs)-derived cells to treat severe myopia.
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Embryonic stem cell-based trial was designed to assess the hESC-derived ACT's retinal pigment epithelial (RPE) cells in patients with severe myopia (nearsightedness).
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  _  F% f4 Y0 ?! R* c8 }5 nACT chairman and CEO Gary Rabin said, "We are pleased to be on track to broaden the scope of our RPE program with the initiation of the new Investigator IND."
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/ w7 D6 Q8 Z1 BAround 12 patients are expected to be enrolled with cohorts of three patients in an ascending dosage design in the myopia trial.
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" k( A! B7 D2 ^+ X5 y/ JThe primary endpoint of the prospective, open-label study is to assess the safety and tolerability profile of hESC-derived RPE cells subsequent to sub-retinal transplantation into myopia patients at 12 months.
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4 l3 v) m; j( M- zACT chief scientific officer Robert Lanza said, "Myopia is one of the most common medical ailments in the world and myopic patients have a higher risk of permanent vision loss due to complications such as fissures in the RPE layer of the eye."