Timothy D. Henry   美国明尼苏达大学

    <International Circulation>: Earlier clinical trials have proven cellular therapy effective in treating refractory angina. What is the present clinical status of this technique?

  《国际循环》：较早期的临床试验已经证明细胞治疗在顽固性心绞痛治疗中是有效的。这一技术的临床现状如何？

    Dr Henry:  Currently we have Phase II trials that are positive. But before it can be approved by the FDA， we need a large Phase III trial that is appropriately powered to look both at events and needs to confirm the improvement in exercise time and reduction in angina. The problem now is in the United States. There are places around the world where people are using cell therapy for refractory angina already but I think it is best done through randomized trials. It is an issue that varies tremendously from country to country in terms of regulations. In the United States it will be not available until there has been a positive Phase III trial and it is approved by the FDA specifically for therapy. Obviously this is potentially important in a country such as China with so many people in need， but I think the key there is to do things in well-designed clinical trials so that you learn things. Not only do you find if it is safe and if it is effective but you can answer questions like: how much to give; how often to give; what is the best method of delivery， and so on. The beauty of this internationally is if we can co-ordinate the trials so that they are all done in a well-designed way so that， within a year from now， we would know the answers to some of these questions.

    Henry博士：目前，我们II期临床试验是阳性的。但要获得FDA批准，我们仍需要进行一项大规模的有适当效能的III期临床试验，以观察对临床事件的影响，还需要确定其对运动时间和减少心绞痛上的改善，因为这是在美国。世界各地有某些地方人们已经在用细胞治疗来治疗顽固性心绞痛，但我认为最好还是经过随机试验验证。在法规方面，国家与国家之间的差别极大。在美国，III期临床试验出现阳性结果并得到FDA专门批准用于治疗之前，是禁止使用的。显然，在如中国这样一个有如此庞大的有需要人口的国家中，这具有潜在的重要性，但我认为关键是在设计良好的临床试验中工作能够学到更多东西。你不仅要发现它是否安全、是否有效，还要回答如下问题：给予多少；多长时间给予一次；输送的最佳方法是什么等等。这种国际性的好处是，如果我们能够对试验进行协调以保证其均以设计良好的方式完成，那么从现在开始的一年内，我们将会知道这些问题的部分答案。

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