Medipost completes first dose of Cartistem in phase 3 clinical trials in Japan

Korea's biotech company plans to evaluate safety and efficacy in 130 patients with knee osteoarthritis

Medipost completes first dose of Cartistem in phase 3 clinical trials in Japan
Jae-Young Han 1
2023-01-17 09:49:32 jyhan@hankyung.com
Bio & Pharma

South Korea's stem cell research company Medipost Co. said on Monday that it has completed the administration of Cartistem, a stem cell treatment for osteoarthritis, to the first patient in a phase 3 clinical trial in Japan.

Cartistem received approval for a phase 3 clinical trial from Japan's Ministry of Health, Labor and Welfare in Feb. 2021 and started clinical trials in March last year, but the clinical plan has been delayed due to COVID-19.

In phase 3 clinical trial, a total of 130 patients with mild to moderate knee osteoarthritis will be divided into the Cartistem-administered group and the hyaluronic acid-administered control group to evaluate its safety and efficacy.

"As the local COVID situation in Japan has eased, we will be able to secure clinical trial hospitals and speed up the enlistment of patients, so that we can complete patient registration and medication as soon as possible. We hope to produce good results in phase 3 clinical trial in Japan and we will do our best to make it a year to lay the foundation for global reach," said a Medipost official.

Cartistem is an allogeneic umbilical cord blood-derived mesenchymal stem cell treatment for patients with knee osteoarthritis caused by degenerative or repetitive trauma. In Korea, it received approval from the Ministry of Food and Drug Safety back in 2012.

The domestic clinical results were recognized in Japan, and the phase 1 and 2 clinical trials were skipped and the company entered phase 3 directly.

Write to Jae-Young Han at jyhan@hankyung.com
#Medipost #Cartistem #osteoarthritis #phase 3 clinical trial #allogeneic umbilical cord blood-derived mesenchymal stem cell #korea medipost cartistem japan

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