Nature Cell announced on the 13th that its stem cell treatment “Astrostem-V,” which was developed to treat pneumonia and lung damage caused by COVID-19, has received US FDA approval to launch a phase 1/2a clinical trial. This is the first Investigational New Drug (IND) for indications of COVID-19 as a domestic stem cell treatment.
Accordingly, Nature Cell plans to select a local Contract Research Organization (CRO) as an agency for clinical trials this month and start recruiting patients from October at a hospital in Los Angeles. For the upcoming clinical trial, which will be carried out on a total of 10 local patients, the progress of the patients will be observed for 12 weeks following a single injection of the clinical trial drug, Astrostem-V. The final result is expected to be deduced around the first half of 2021.
The clinical trials are for adults between the ages of 19 to 80 who have been diagnosed with pneumonia and lung damage due to COVID-19. A patient will be given a dose of Astrostem-V, a clinical trial drug that separates and cultivates stem cells from adipose tissues of direct family members such as parents, children, and siblings, and observed for the following 12 weeks in order to evaluate the drug’s safety and effectiveness.
The Astrostem-V administered in the clinical trials is to be manufactured in Korea and distributed to local sites through airlifts. Nature Cell explained that this is possible since the Biostar research institute has secured distinctive stem cell technology.
Earlier on April 17, Nature Cell submitted an Astrostem-V clinical protocol to the FDA for administering adipose tissue-derived stem cells from the parents, children, or siblings to pneumonia patients of COVID-19. Since then, Nature Cell has gone through the process of consultation with the FDA and data supplementation and received a notice of final approval of the investigational drug.
“I am very pleased to contribute to the work of saving lives. We will do our best in saving the lives of Americans through Korea’s local stem cell technology,” Astrostem’s chief development officer, Doctor Ra Jeong Chan, stated.