L&C Bio, MegaCarti IRB Approval

Regenerative medicine specialist L&C Bio Co., Ltd. (290650, CEO Hwancheol Lee)'s knee cartilage osteoarthritis treatment, 'MegaCarti,' has received approval from four clinical trial institutions, allowing the clinical trials to officially commence.

After receiving approval for the clinical trial plan (IND) from the Ministry of Food and Drug Safety on December 27, 2019, the four hospitals conducting the clinical trials (Yonsei University Severance Hospital, Gangnam Severance Hospital, Korea University Anam Hospital, National Health Insurance Service Ilsan Hospital) proceeded with the IRB (Institutional Review Board) approval process, which was finally completed on March 20.

This clinical trial will be conducted at the four hospitals, involving a total of 90 patients with knee joint cartilage damage (degenerative arthritis with ICRS grade 3 to 4). MegaCarti will be implanted and patients will be followed up for one year to evaluate efficacy and safety.

A representative from L&C Bio Co., Ltd. stated, “With 3.87 million patients suffering from degenerative arthritis in Korea, we expect the clinical recruitment to be completed soon. Compared to existing treatments, MegaCarti offers faster pain relief and price competitiveness, which we believe will greatly benefit patients struggling with degenerative arthritis.”