ROKIT Healthcare said on the 17th that it will launch a joint study with the research team of Dr. Joseph Bonventre, a Harvard Medical School professor, to validate the efficacy of organ regeneration technology.
Professor Bonventre is regarded as an authority in nephrology and regenerative medicine. He is a Harvard Medical School professor and a key figure on the research team at Brigham and Women's Hospital. He is known as the researcher who discovered the biomarker "KIM-1 (Kidney Injury Molecule-1)" for early diagnosis of kidney injury, and he served as president of the American Society of Nephrology (ASN).
The research team plans to conduct scientific validation of ROKIT Healthcare's 3D bioprinting-based, personalized regenerative patch. Using an animal model of chronic kidney disease (CKD), they will analyze whether the platform suppresses renal tissue fibrosis and preserves and improves function.
ROKIT Healthcare plans to use the results of this joint study as supporting data for entry into the U.S. market. The team will combine data secured by Professor Bonventre's group with existing clinical evidence obtained at Asan Medical Center to apply for the U.S. Food and Drug Administration's (FDA) Expanded Access Program (EAP). The EAP allows the use of investigational drugs or medical devices in clinical trial stages for patients with serious conditions who lack appropriate alternative therapies.
According to the company, in nonclinical studies the kidney regeneration platform reduced the area of renal fibrosis by 50.4%, and levels of KIM-1, a biomarker of kidney injury, decreased by 42.5%.
However, the company applied a conservative analysis in light of the possibility that efficacy may decrease in human application. In a simulation assuming the efficacy seen in animal studies drops to about 50% in humans, the analysis showed that if about 35% antifibrotic effect is maintained, the start of dialysis could potentially be delayed by about three to four years. The company plans to verify this potential through future clinical trials.
A ROKIT Healthcare official said, "Through this study, we plan to secure scientific evidence for kidney regeneration technology and pursue entry into U.S. clinical trials."