The artificial intelligence (AI)-based organ regeneration platform corporations ROKIT Healthcare(376900) will begin an advanced regenerative medicine clinical study on kidney regeneration at a tertiary hospital in Korea.
The company said this trial is the world's first case of kidney regeneration surgery in humans.
ROKIT Healthcare said on the 13th that, after receiving approval from the Institutional Review Board (IRB) for advanced regenerative medicine clinical research at a tertiary hospital, 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, ROKIT Healthcare received approval for its advanced regenerative medicine research plan from the Ministry of Health and Welfare in May, and with this IRB approval, it completed the procedures required for the trial.
This 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 patient-specific regenerative patches. ROKIT Healthcare has secured patents related to the 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, preclinical studies conducted by researchers at Harvard Medical School and Seoul National University found a kidney function regeneration rate of about 63% and about a 70% reduction in renal fibrosis. The company also said microvascular density increased about threefold, renal vascular resistance decreased by about 20%, and kidney structure preservation reached about 90%.
A ROKIT Healthcare official said, "We plan to push for approval of advanced regenerative medicine treatment after confirming the safety and efficacy of kidney regeneration therapy through this trial," adding, "We will continue development so that it can become a new option for treating chronic kidney disease."