Korea’s ‘JointStem’ Adipose Stem Cell Therapy gets FDA Breakthrough Therapy Designation for Osteoarthritis
Nature Cell Co., Ltd. announced that its cell therapy product, JointStem, has been granted Breakthrough Therapy Designation (BTD) by the U.S. FDA, marking a first for a Korean company in this field. This designation is expected to expedite the development and approval process of JointStem, which is currently undergoing clinical trials in the United States.
Following its designation as a Regenerative Medicine Advanced Therapy (RMAT) by the FDA in October 2023, JointStem has now received Breakthrough Therapy Designation (BTD) based on results from its Phase 3 clinical trials and long-term follow-up studies conducted in South Korea.
The therapy is currently undergoing clinical trials for knee osteoarthritis in the USA
BTD is granted to clinical trials that demonstrate a clinically significant improvement over existing treatment options. Companies receive the full benefits of Fast Track designation, and it helps facilitate direct engagement with senior FDA officials.
In addition to ‘street cred’, BTD could potentially increase the likelihood of product approval and reduce the regulatory timeline, thereby accelerating the pathway to commercialization.
For instance, Imbruvica, a targeted cancer therapy developed by AbbVie and Janssen Biotech, received BTD in 2013 and was designated for priority review, leading to FDA accelerated approval within one year. Similarly, Keytruda, an immunotherapy developed by Merck (MSD), also received BTD and priority review, resulting in accelerated approval in approximately one year.
JointStem is reported to be the world’s first autologous adipose-derived mesenchymal stem cell therapy (using stem cells from a person’s own fat tissue) specifically intended for patients with severe knee osteoarthritis. A single intra-articular injection has reportedly been shown to stimulate cartilage regeneration, significantly reduce pain, and improve joint function for at least three years, potentially delaying or eliminating the need for knee replacement surgery.
The parent company making the product is called Biostar, based in South Korea. Under this, are Stemcellbio (USA), Nature Cell (South Korea), and JASC (Japan). Biostar has a couple of stem cell products listed on their site, including ones for COVID and Alzheimer’s.
They also appear to make a variety of stem cell/exosome-based beauty products.
