[약업신문]Nature Cell completes all patient follow-up in JointStem Phase 3 clinical trials

Nature Cell Co., Ltd. is a joint venture conducted for a total of 247 patients with severe degenerative arthritis of grade 3 KL at 13 university hospitals nationwide including Kangdong Kyunghee University Hospital, Seoul National University Hospital, Severance Hospital, and Samsung Seoul Hospital, which are domestic clinical trials for’Jointstem’. It was announced on the 29th that the 6-month follow-up of the stem phase 3 clinical trial was completed. The JointStem, a treatment for severe knee degenerative arthritis using autologous adipose-derived mesenchymal stem cells, was developed by RBIO, and Nature Cell owns the domestic copyright.

According to the company, 261 patients were enrolled in this clinical trial, of which 252 patients were administered investigational drugs, of which 6 months follow-up observation was completed for the final 247 patients excluding 14 patients who dropped out and withdrew consent . This is the largest number of patients in clinical trials for stem cell therapy in Korea.

The joint-stem phase 3 clinical trial was previously approved by the Ministry of Food and Drug Safety on January 31, 2019, and in July of the same year, the clinical trial drug was administered to the first patient at Gangdong Kyunghee University Hospital. For about 11 months, clinical trial drugs were administered to 252 patients at 13 clinical trial institutes nationwide (university hospitals) including Seoul National University Hospital, Gangnam Severance Hospital, Seoul St. Mary’s Hospital, and Samsung Seoul Hospital. Thereafter, follow-up observation of each patient was conducted, and the last 6 months of follow-up observation of the last patient was completed on December 15 this year.

Accordingly, Albaio has entered the procedure for terminating the clinical trial with the CRO, and the results are expected to be drawn in the first quarter of next year, the company said.

Dr. Jeong-Chan Ra, head of Joint Stem Research and Development Director of BioStar Stem Cell Technology Research Institute, said, “We will make thorough preparations so that we can obtain a joint stem product license in 2021.”