Nature Cell’s JointStem passed FDA 2b/3a review
By The Asia N Editor
FDA Approves JointStem, a arthritis-specialized stem cell therapy offered by Nature Cell, which passed the 2b/3a review.
Nature Cell Co., Ltd. (CEO Ra Jung-chan) announced on the 20th that “Jointstem, the world’s first self-fat-derived mid-leaf cell treatment for severe degenerative arthritis, passed the U.S. Food and Drug Administration’s commercial clinical 2b/3a review.” This provides a meaningful opportunity to open the era of treating U.S. patients with Korean stem cell technology.
“We believe that the passage of the FDA review was possible because the results of the safety and validity search were successfully presented through clinical tests conducted in Korea (two times) and the U.S. (one time) as well as the development of joint system manufacturing methods and quality control methods,” a Nature Cell official said. “By passing the FDA’s review, we will immediately start preparing for the clinical trial.”
Nature Cell plans to complete necessary preparation procedures, including the selection of a clinical trial agency in the U.S. within the first half of this year, before starting recruiting patients in the second half. If carried out as planned, all clinical trials will be completed by 2022.
Clinical trials will evaluate the efficacy and safety of Jointstem against knee degenerative arthritis. Clinical trials are conducted on a total of 140 patients, with a ratio of one to one, randomly assigned test group and control group of 70 each. Participating patients will be given clinical trial drugs that include 100 million cells of stem cell drugs separated and cultivated from their local tissues under double blindness, and follow-up observations will take place over the next 12 months.
Nature Cell previously submitted a joint-stem 2b/3a clinical trial plan to the FDA on March 17 and passed the final screening after coordinating opinions from both sides. The FDA is applying a screening system instead of an approval for a clinical plan, which has the same effect as approval.
Ra Jung-chan, CEO of Nature Cell, said, “I would like to thank all the members of the Biostar family, including the researchers who did their best to pass the screening. We will do our best to make a new day when degenerative arthritis patients around the world, mainly in the U.S., are treated with the technology of the Republic of Korea come as soon as possible.