Rokit Healthcare (376900) said on the 13th that it has received advanced regenerative medicine clinical approval for its kidney regeneration procedure from the Institutional Review Board (IRB) for Advanced Regenerative Medicine at Asan Medical Center, and will begin human clinical surgery this month. It marks the world's first attempt to verify the regenerative potential of kidney tissue using a patch derived from cells taken from the patient's own fat membrane tissue (omentum).
Asan Medical Center and Rokit Healthcare completed all approval procedures after receiving advanced regenerative medicine research plan approval at the Ministry of Health and Welfare's "6th Advanced Regenerative Medicine and Advanced Biopharmaceutical Review Committee" held in late May. The method involves extracting the "omentum tissue" from the peritoneal layer of chronic kidney disease patients, mixing it with a "fibrin glue" scaffold made of medical adhesive, and implanting it beneath the kidney capsule. Because the patient's own tissue is used, immune rejection can be fundamentally prevented. The procedure applies a cutting-edge convergence technology that combines an artificial intelligence (AI)-based 3D bioprinter with advanced robotic surgery to precisely implant a customized regeneration patch.
The core technology applied in this surgery has already completed patent registration in the United States, Japan, and Korea.
Beginning this month, the two institutions will perform surgery on 10 chronic kidney disease patients, turning tissue collected from each patient into bioink, fabricating it into a patch, and implanting it on the surface of the kidney, and will evaluate the possibility of restoring kidney function. Rokit Healthcare had previously confirmed the regenerative effect of its kidney regeneration platform through preclinical studies with researchers at Harvard Medical School in the United States and Seoul National University. According to the preclinical results, the kidney function regeneration rate reached approximately 63%, and kidney fibrosis was reduced by approximately 70%. In addition, microvascular density increased approximately threefold, kidney vascular resistance decreased approximately 20%, and the kidney structure preservation rate was maintained at approximately 90%. The company believes that the success potential of this clinical trial has been further raised by incorporating the expertise of Asan Medical Center, which has performed a cumulative total of 8,000 kidney transplants. Given the clear limitations of conventional dialysis- or transplant-centered treatment, the company expects that a paradigm shift in chronic kidney disease treatment will be possible if this clinical trial succeeds.
"As soon as this clinical trial is completed, we plan to pursue rapid approval of advanced regenerative treatment," a Rokit Healthcare official said. "We will not only provide a 'dialysis-free life' to 800 million chronic renal failure patients at home and abroad, but also strive to develop Korea into a 'global kidney regeneration medical hub.'"
