日本委员会批准两款iPS细胞衍生药物 全球首例

日本厚生劳动省专家委员会周四批准了两款源自iPS细胞的再生医学产品商业化,这是全球首例。这些治疗针对严重心力衰竭和帕金森病患者,属于条件批准,需要收集长达七年的数据。iPS细胞研究先驱山中伸弥对此里程碑表示欣喜。

日本厚生劳动省专家委员会周四建议部长批准两款使用诱导多能干细胞(iPS细胞)的再生医学产品的生产和销售,这些产品有望成为全球首例此类产品之一。

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Scientists in a lab celebrating conditional approval of iPS cell products for treating Parkinson's and heart disease.
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厚生劳动省专家小组有条件批准iPS细胞产品

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厚生劳动省专家小组有条件批准了两款用于治疗帕金森病和严重心脏病的诱导多能干(iPS)细胞衍生再生医学产品。这标志着诺贝尔奖获奖干细胞技术商业化的潜在世界首例。该批准基于小规模临床试验确认的安全性和假定疗效,要求在七年内在上市后进行验证。

Doctors at Keck Medicine of USC are implanting lab-grown, dopamine-producing cells into the brains of people with Parkinson’s disease in an early-stage clinical trial that will enroll up to 12 participants across three U.S. sites.

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Keck Medicine of USC researchers are testing an experimental approach to Parkinson’s disease that implants lab-grown, dopamine-producing cells into a movement-control region of the brain. The early-stage Phase 1 REPLACE trial involves up to 12 people with moderate to moderate-severe Parkinson’s disease, and the U.S. Food and Drug Administration has granted the study fast-track designation.

A Cold Spring Harbor Laboratory study demonstrated CAR T-cell therapy can reverse age-related intestinal decline in mice by targeting senescent cells. While promising, experts caution on safety risks, off-target effects, dosing, and costs for human use.

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Cold Spring Harbor Laboratory researchers report that engineered anti-uPAR CAR T cells cleared senescence-linked cells in mice, improving intestinal regeneration, reducing inflammation and strengthening gut barrier function. The approach also aided recovery from radiation-related intestinal injury and showed regenerative signals in experiments using human intestinal and colorectal cells, raising the possibility of future clinical trials.

Duke-NUS Medical School researchers, working with the University of Sydney, have developed BrainSTEM—a two-tier, single-cell atlas of the developing human brain that profiles nearly 680,000 cells. Published online in Science Advances on October 31, 2025, the resource focuses on midbrain dopaminergic neurons, flags off‑target cell types in lab-grown models, and will be released openly for the research community.

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日本文部科学省已将东京科学大学认证为有资格获得10万亿日元政府基金援助的第二所大学。该大学由东京工业大学和东京医科齿科大学于2024年合并而成,预计首年获得超过100亿日元的补贴。该认证支持加强医学与工程研究人员合作的计划。

 

 

 

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