In the News Reporter Seo-Jung Kimㅣ On the 29th, Nature Cell announced that the 6-month follow-up of the JointStem Phase 3 clinical trial, a treatment for severe knee degenerative arthritis using stem cells, has been completed.
This is the result of a total of 247 KL grade 3 severe degenerative arthritis patients 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.
JointStem was developed by Albaio, and Nature Cell owns the domestic copyright.
The joint stem phase 3 clinical trial was approved by the Ministry of Food and Drug Safety on January 31 of last year, and in July of the same year, the clinical trial drug was administered to the first patient at Gangdong Kyunghee University Hospital.
Over the next 11 months, 13 clinical trial institutions (university hospitals) nationwide, including Seoul National University Hospital, Gangnam Severance Hospital, Seoul St. Mary’s Hospital, and Samsung Seoul Hospital, administered clinical trial drugs to 252 patients. The patient’s last 6 months follow-up was completed.
In this clinical trial, a total of 261 patients were enrolled, of which 252 patients were administered investigational drugs, of which 6 months follow-up was completed for the final 247 patients, excluding 14 patients who dropped out and withdrew consent. The company explained that this is the largest number of patients in clinical trials for stem cell treatments in Korea.
Albaio has entered the clinical trial termination procedure with the Clinical Trial Trustee (CRO), and is expected to produce results in the first quarter of next year.
Dr. Jeong-Chan Ra, head of the Research Institute of Biostar Stem Cell Technology, who is in charge of joint-stem research and development, said, “In 2021, we will make thorough preparations so that we can obtain a product license from Joint-Stem.”