The world's first allogeneic adipose derived mesenchymal stromal cells (AD MSCs) drug (NR-20201) developed by Tianshi Pharmaceutical Group Co., Ltd. for the treatment of acute ischemic stroke received clinical trial approval from the US Food and Drug Administration (FDA) on October 26, 2024.

It is reported that in the process of developing NR-20201, the company used artificial intelligence to analyze single-cell transcriptomics, cell life trajectories, and fate outcomes [1,2], confirming that the AD MSCs produced by Tasly's standard preparation process are mesenchymal stromal cells rather than mesenchymal stem cells. Based on the difference between stromal cells and stem cells, this product has unique identification criteria and a mechanism of action different from stem cells. This product selects a suitable treatment time window based on the patient's condition, promoting effective homing of cells after intravenous infusion. After cell homing, it works synergistically with endothelial cells to activate vascular regeneration and functional repair in damaged brain tissue, ensuring stable treatment for acute ischemic stroke. Therefore, it has become the world's first mesenchymal stromal cell drug product.

Source: https://pharm.jgvogel.cn/c1456512.shtml