Expected to Benefit from FDA’s Accelerated Approval Program with RMAT Designation
Nature Cell, led by CEO Joo-sun Kim and Dae-jung Byun, announced that its stem cell therapy for severe degenerative arthritis, "JointStem," was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) on October 22. This designation, part of the FDA’s fast-track program established under the 21st Century Cures Act of 2016, expedites the development and approval process for regenerative treatments.
To qualify for RMAT designation, therapies must meet FDA criteria as regenerative medicine, target a serious disease, demonstrate potential for treatment or cure, and address unmet medical needs through preliminary clinical evidence.
JointStem completed three clinical trials in South Korea with advanced knee osteoarthritis patients (Kellgren-Lawrence Grade 3), showing significant improvement in knee pain and function among patients unresponsive to standard treatments, with no severe adverse effects. Additionally, a three-year follow-up from a Phase 3 trial suggested potential cartilage regeneration.
A Nature Cell spokesperson remarked, “The RMAT designation for JointStem reflects a comprehensive review of South Korea’s Phase 3 trial results and follow-up data. This designation will accelerate the approval process in both Korea and the U.S., bringing us closer to offering relief for knee osteoarthritis patients worldwide.”