LOS ANGELES, CA / ACCESSWIRE / October 25, 2024 / On October 23rd, Nature Cell Co., Ltd. proudly announced the receipt of RMAT designation for "JointStem," an innovative treatment for severe degenerative arthritis, from the U.S. FDA.
The RMAT initiative by the U.S. FDA is designed to accelerate the development and approval of groundbreaking regenerative drugs that tackle critical medical needs, a revision made under the 21st Century Cures Act in 2016, serving as a fast-track system for pioneering advanced regenerative therapies. With RMAT designation, drugs can fully leverage the FDA's expedited license development program.
A drug is eligible for RMAT designation if it can effectively treat, modify, recover, or cure a serious disease or condition and meets criteria for regenerative medical treatment, backed by preliminary clinical evidence demonstrating its capacity to address unmet medical needs for that condition.
JointStem has achieved success in three clinical trials in Korea focused on patients with severe knee degenerative arthritis classified as Kellgren-Lawrence Grade 3. It has proven to be completely safe for patients who have not benefited from the current Standard of Care (SOC), demonstrating clear symptom relief, including reduced knee pain and improved functionality. In addition, long-term follow-up observations over three years post-phase 3 clinical trial in Korea have confirmed the promising ability to regenerate damaged cartilage.
A representative from Nature Cell Co., Ltd. declared, "The RMAT designation for JointStem is a significant milestone, resulting from meticulous evaluation by the FDA, reflecting the outcomes of phase 3 clinical trials in Korea and comprehensive three-year follow-up studies. We are committed to accelerating the development process following RMAT approval to revolutionize treatment for knee degenerative arthritis worldwide, pursuing product approval not just in Korea but also in the United States."
Contact Information:
janeshin@stemcellbio.com
SOURCE: Stemcell Bio, Inc.
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