东京——日本科学省计划开发更易于在临床环境中使用的诱导多能干细胞(iPS细胞),希望利用这类细胞治疗中风和慢性肾衰竭等疾病,并降低生产成本。
TOKYO -- Japan's science ministry plans to develop induced pluripotent stem (iPS) cells that are easier to use in clinical environments, with the hope of treating conditions such as strokes and chronic kidney failure, as well as lowering production costs.
该部正将这项技术定位为“下一代”iPS细胞,并在2027财年预算申请中为该项目拨款56亿日元(3560万美元)。
The ministry is positioning the technology as "next-generation" iPS cells, and has earmarked 5.6 billion yen ($35.6 million) for the initiative in its fiscal 2027 budget request.
该部门计划在2027财年完成这种细胞生产方法的开发。京都大学CiRA基金会将建立一条生产线,面向研究及其他用途的供应拟于2028财年开始。该计划要求在2030财年建立量产体系。
It aims to complete the cell production method in fiscal 2027. A production line will be set up at the CiRA Foundation at Kyoto University, with distribution for research and other purposes scheduled to begin in fiscal 2028. The plan calls for a mass-production system to be in place in fiscal 2030.
iPS细胞由京都大学教授山中伸弥于2006年发现。研究人员将特定基因导入皮肤细胞等细胞中进行培养,从而生成iPS细胞。这些细胞可以分化成任何组织或器官的细胞。
iPS cells were discovered in 2006 by Kyoto University professor Shinya Yamanaka. They are created by introducing specific genes into skin and other cells and then culturing them. The resulting cells can develop into cells of any tissue or organ.
然而,目前的生产方法面临诸多挑战,包括质量不稳定,以及iPS细胞分化为目标细胞类型的比例较低。这使这类细胞实际上无法用于治疗涉及大脑和肾脏等复杂器官的疾病。
However, current production methods face challenges, including inconsistent quality and the low rate at which iPS cells develop into the desired cell types. This has made it effectively impossible to apply them to diseases involving complex organs, such as the brain and kidneys.
为克服这些难题,CiRA基金会一直致力于改进iPS细胞的生产方法。研究显示,改变培养条件,使细胞回到更接近受精卵早期阶段的状态,可以提高其分化为目标细胞类型的能力。
To overcome this, the CiRA Foundation has been working to improve iPS cell production methods. Research has shown that altering culture conditions to return cells to a state closer to the early stages of a fertilized egg can improve their ability to develop into the desired cell type.
这项技术或许能够复制器官的复杂结构。例如,制造大脑皮层细胞将变得更容易。大脑皮层是负责高级思维的大脑薄层。
This technique could make it possible to reproduce the complex structures of organs. For example, it has become easier to create cells for the cerebral cortex, the thin layer of the brain responsible for high-level thinking.
如果利用iPS细胞培育出类似大脑皮层的微型器官——即类器官——并将其移植到患者体内,就有可能改善中风导致的运动功能减退。日本目前约有130万人正在接受中风治疗。
If miniature organs -- or organoids -- resembling the cerebral cortex are created from iPS cells and transplanted into patients, they could potentially improve reduced motor function caused by strokes. About 1.3 million people are receiving treatment for strokes in Japan.
新一代iPS细胞还有可能被用于培育肾细胞和肺细胞。预计这些细胞可应用于慢性肾衰竭和肺气肿等疾病的治疗;在肺气肿患者中,肺泡受损会导致呼吸困难。
Next-generation iPS cells could also potentially be used to create kidney and lung cells. They are expected to have applications in conditions such as chronic kidney failure and emphysema, where damage to the alveoli in the lungs makes breathing difficult.
科技部门的相关计划还旨在降低细胞制造成本。目前,向患者递送细胞每例需要花费5000万日元至数亿日元。要让此类治疗得到普及,成本必须降下来。新一代iPS细胞能否投入实际应用,被认为实现这一目标的关键。
The science ministry's initiative also aims to cut cell manufacturing costs. Delivering cells to patients currently costs between 50 million yen and several hundred million yen per case. For such treatments to become widely available, costs will need to come down. The practical application of next-generation iPS cells is considered critical to achieving that goal.
如今,在iPS细胞被发现20年后,第一代iPS细胞在医疗领域的应用正逐步全面展开。
Now, 20 years after the discovery of iPS cells, medical applications of first-generation iPS cells are beginning in earnest.
3月,两种产品成为全球首批获得有条件且限期监管批准的iPS细胞再生医学产品:住友制药开发的帕金森病治疗产品,以及大阪大学孵化的初创公司Cuorips开发的心力衰竭心肌细胞片。
In March, two products became the world's first regenerative medicines using iPS cells to receive conditional, time-limited regulatory approval: a treatment for Parkinson's disease developed by Sumitomo Pharma and cardiac muscle cell sheets for heart failure developed by Cuorips, a startup out of the University of Osaka.
松下控股已经开发出能够全自动培育细胞的新型设备。由于新一代iPS细胞的培养流程与第一代细胞高度重合,因此只需对现有设备进行改造,就有可能使其适用于新细胞。
Panasonic Holdings has developed equipment capable of fully automated cell cultivation. Because the cultivation process for next-generation iPS cells significantly overlaps with that for first-generation cells, it may be possible to handle the new cells by modifying existing equipment.
日本政府内阁于7月批准的增长战略,将采用iPS细胞的再生医学列为日本的优势之一。但美国和中国也在加强相关研究,日本能否保持先发优势仍不确定。
The growth strategy approved by the Japanese government's cabinet in July named regenerative medicines using iPS cells as one of Japan's strengths. But the U.S. and China are also stepping up research, making it uncertain whether the country will be able to maintain its first-mover advantage.
“为了与美国和中国竞争,我们必须能够维持一个覆盖全国的框架,”发现iPS细胞的山中伸弥教授说。下一代iPS细胞能否迅速得到广泛使用,将是决定日本竞争力的关键。
"To compete with the U.S. and China, it's important that we can maintain an all-Japan framework," said Yamanaka, the professor who discovered iPS cells. The speed with which next-generation iPS cells enter widespread use will be key to Japan's competitiveness.