South Korea to start clinical trial to treat severe COVID-19 cases
By Sang-Ki Lee
AsiaN CEO & Publisher
AJA Founder President
Seoul: In the midst of unprecedented chaos resulting from the worldwide COVID-19 outbreak, South Korea is expected to start a clinical trial to treat the severe COVID-19 cases relying on mechanical ventilators with stem cell therapy.
Dr Jeong Chan Ra, chairman of Biostar Stem Cell Research Institute, co-operated by R-Bio and Nature Cell, said on March 10 that the institute requested permission from South Korea’s Ministry of Food and Drug Safety for clinical trials phase 1/2A to treat the serious COVID-19 cases by administering ‘Astrostem-V,’ an autologous stem cell drug intravenously.
According to the lead researcher of Biostar, the clinical trials are targeting aggravated COVID-19 patients with ARDS (Acute Respiratory Distress Syndrome). The patients will be administered Astrostem-V, an autologous adipose tissue derived mesenchymal stem cell drug, two times in total with a one-week interval. Each infusion will include 200 million cells. Safety and efficacy will be assessed four weeks and eight weeks after the injections.
If the trials are approved by the ministry after 30 days of review, the institute will begin the clinical trials without any delay. In addition, Nature Cell is preparing to apply for FDA approval for clinical trials of Astrostem-V in April.
“A recent study showed that COVID-19 patients produce an excessive amount of cytokine, proteins which regulate immunity, which can become a serious issue. Especially when it comes to the severe cases, compared to the others, they experience a so-called ‘cytokine storm,’ characterized by sharp increases of certain cytokines such as ‘GCSP,’ ‘IP10,’ ‘MCP1,’ ‘MIP1A,’ and ‘TNFα.’ It rapidly aggravates the symptoms,” said Dr. Ra.
“We are focusing on the effect of Astrostem-V that effectively restrains the so-called “cytokine storm,” (an overproduction of immune cells) reduces lung damages and develops antibodies in severe patients in need of mechanical ventilators, thus leading them to be cured.
“We found the potential of Astrostem-V treating severe COVID-19 cases effectively with its immunoregulation and anti-inflammatory effects confirmed by several researches including COPD, rheumatoid arthritis, autoimmune thyroiditis and systemic lupus erythematosus.
“Our researchers are studying the efficacy of Astrostem-V with the research team of the veterinary school at Seoul National University by injecting Infectious bronchitis virus that has similar symptoms as COVID-19 into animals’ fertilized eggs to incur lung damages and then administering Astrostem-V.
“Patients who are elderly and/or have underlying diseases are prone to get critically ill, and they are the ones who are likely to get better with the treatment considering how stem cell drug works,” Dr. Ra said. “I hope these clinical trials will be approved as soon as possible so they can help save more lives,” he said.
It was reported that in Hubei, China, the epicenter of COVID-19, a clinical trial of the stem cell therapy which injects cord blood-derived stem cells into severe COVID-19 patients was successful. In this clinical trial, 50 million stem cells were administered at a time, and the infusions were given a total of three times every three days.
Dr. Jeong Chan Ra, the leading authority of Biostar Stem Cell Research Institute is also the author of “The Grace of Stem Cells.” The book has been translated into seven different languages including English, Japanese, Chinese, and Arabic. It is widely read in more than 30 countries.
The Arabic version was translated by Ashraf Dali, the President of the Asia Journalists Association. A publication launch was held in the Egyptian capital Cairo, when it was released in January 2019. Arab journalists and the ambassador of the Republic of Korea to Egypt were invited to the event. The book is also receiving enthusiastic and favorable responses from readers in the book fairs held in Egypt and Dubai.
* Translated by Peter Jaegeul Song, Staff Reporter, Asia N