The artificial intelligence (AI)-based organ regeneration platform corporations ROKIT Healthcare(376900) will begin an advanced regenerative medicine clinical study on kidney regeneration at Asan Medical Center.
The company said this trial is the world's first case of kidney regeneration surgery in humans.
ROKIT Healthcare said on the 13th that, with approval from the Asan Medical Center Institutional Review Board (IRB) for advanced regenerative medicine clinical research, it will conduct clinical kidney regeneration surgeries starting this month for 10 patients with chronic kidney disease.
The core of this trial is to evaluate safety along with the potential for kidney function recovery and tissue regeneration. Earlier, Asan Medical Center and ROKIT Healthcare received approval for an advanced regenerative medicine research plan from the Ministry of Health and Welfare in May, and, with this IRB approval, completed the procedures required for the clinical trial.
This clinical trial applies a kidney regeneration technology that uses autologous cells derived from the patient's omentum tissue. It combines AI-based 3D bioprinting technology with robotic surgery to produce and implant a patient-specific regenerative patch. ROKIT Healthcare has secured patents related to this technology in the United States, Japan, and Korea. The company said that using the patient's own cells can reduce the likelihood of immune rejection.
According to the company, in preclinical studies conducted by researchers at Harvard Medical School and Seoul National University, results showed about a 63% regeneration rate in kidney function and about a 70% reduction in renal fibrosis. The company also said that microvascular density increased by about threefold, renal vascular resistance decreased by about 20%, and kidney structure preservation reached about 90%.
A ROKIT Healthcare official said, "After confirming the safety and efficacy of kidney regeneration therapy through this clinical trial, we plan to seek approval for advanced regenerative medicine treatment," adding, "We will continue development so it can become a new alternative for treating chronic kidney disease."