Rokit Healthcare's kidney regeneration patch under development has received approval from the Ministry of Health and Welfare for an advanced regenerative medicine clinical study. With pilot human trials potentially beginning as early as this month, the approval is expected to mark a new turning point in organ regeneration therapy.
According to industry sources on Wednesday, the recently held 6th Advanced Regenerative Medicine and Advanced Biopharmaceutical Review Committee of the Ministry of Health and Welfare cleared a clinical study that extracts "omentum tissue" from the peritoneal layer of chronic kidney disease patients, mixes it with a fibrin glue scaffold — a medical adhesive — and implants it beneath the kidney capsule. The study utilizes the artificial intelligence (AI) kidney regeneration platform that Rokit Healthcare is developing. Tissue harvested from the patient is turned into bio-ink and fabricated into a patch, which is then implanted on the surface of the kidney to evaluate the potential for restoring kidney function.
"We are preparing a clinical trial at Asan Medical Center targeting 10 end-stage renal failure patients who require dialysis or kidney transplantation," a company official said. "Patient recruitment could begin as early as June."
Chronic kidney disease is a condition in which kidney damage or functional decline, caused by hypertension or diabetes, persists for more than three months. Currently, there is no treatment that can reverse kidney fibrosis or tubular damage that has already progressed.
In a recent preclinical trial conducted with researchers at a Harvard Medical School-affiliated hospital, Rokit Healthcare obtained results showing that kidney function was regenerated and maintained in 62.5% of subjects implanted with the omentum patch. The company plans to complete a domestic pilot clinical trial in the second half of this year and accelerate commercialization through large-scale global clinical trials.
"Through validation with Harvard Medical School, we have effectively eliminated technical risks and secured biological validity," a Rokit Healthcare official emphasized.
