Regen Med. 2011 Nov;6(6 Suppl):11-3. doi: 10.2217/rme.11.77.
Geron's Chief Scientific Officer, Jane Lebkowski, discusses the long road to clinical trials and the next steps for GRNOPC1. The long-awaited clinical trial of Geron's GRNOPC1 therapy for spinal cord injury has been one of the biggest stories in regenerative medicine over the past few years. The trial initially received the go-ahead from the US FDA in early 2009, but was put on clinical hold soon afterwards when an increased frequency of cysts was found in an animal experiment. Revision in release criteria and additional prospective animal studies allayed these concerns and the clinical hold was finally lifted in June 2010. The Phase I clinical trial enrolled its first patient in October 2010. As the world's first human trial of an embryonic stem cell-derived therapy, the trial has generated a huge amount of attention.
杰龙公司的首席科学官简·莱博夫斯基（Jane Lebkowski）讨论了通往临床试验的漫长道路以及 GRNOPC1 的下一步计划。在过去几年中，杰龙公司的 GRNOPC1 治疗脊髓损伤的临床试验一直是再生医学领域最大的新闻之一。该试验最初于 2009 年初获得美国 FDA 的批准，但随后在动物实验中发现囊肿的频率增加后被临床搁置。释放标准的修订和额外的前瞻性动物研究减轻了这些担忧，临床搁置最终于 2010 年 6 月解除。该 I 期临床试验于 2010 年 10 月招募了第一名患者。作为世界上首例胚胎干细胞衍生疗法的人体试验，该试验引起了广泛关注。
