Allogeneic cell therapy product CARTISTEM® will undergo a Phase 3 clinical trial to expand indications.
MEDIPOST announced on the 3rd of this month that the Ministry of Food and Drug Safety(MFDS) has approved the Phase 3 clinical trial of CARTISTEM® for the treatment of patients with ankle joint osteochondral cartilage defects.
This trial will be conducted as a randomized, multi-center, single-blinded stratified study.
A total of 100 patients will be randomly assigned in 1:1 ratio, to either the control group with micro-fracture procedure alone, or the treatment group with the combination of micro-fracture together with the administration of allogeneic cord blood-derived mesenchymal stem cell therapy product CARTISTEM®.
Following 48-weeks of the observation period, the safety and efficacy of CARTISTEM® will be assessed.
MEDIPOST plans to transfer the clinical trial rights to SK Bioland for the efficient progress of the clinical trial.
MEDIPOST and SK Bioland executed the “Exclusive domestic distributorship of CARTISTEM® for the ankle joint indication” agreement on December 31 of last year.
A MEDIPOST official said, “Currently available surgical treatment options provide only limited effects on cartilage damage in the ankle joint with very poor long-term prognosis” and that they “hope to achieve meaningful therapeutic effects such as regeneration of cartilage in the ankle joint, by administering CARTISTEM® which has gained clinical credibility through data accumulated on the market over the past 7 years.”