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Adult Stem Cell Therapy for COVID-19 Sequelae Begins in Japan for the First Time in the World

LOS ANGELES, CA, UNITED STATES, December 8, 2020 /EINPresswire.com/ -- Adult Stem Cell Treatment for COVID-19 Sequelae Begins in Japan
for the First Time in the World

Japan's Kyushu Certified Special Committee for Regenerative Medicine, Appropriate Opinion on Treatment Plan for COVID-19 Sequelae Using Autologous Adipose-derived Mesenchymal Stem Cells
The patented technology developed by Korea's Biostar Stem Cell Research Institute is scheduled to start in late December at the Japanese medical corporation Yesunghoe Trinity Clinic Fukuoka

Stem cell therapy developed in Korea to treat sequelae resulting from COVID-19 infection is being launched for the first time in Japan. Recently, the risk is rapidly increasing with patients from all over the world, and the third wave of the pandemic has started.

Nature Cell, a revolutionary stem cell bio company announced on the 8th of December that Yesunghoe Trinity Clinic Fukuoka, a Japanese affiliate hospital received the approval from the Certified Special Committee for Regenerative Medicine for the treatment of COVID-19 sequelae using fat-derived mesenchymal stem cells.

The committee composed of 16 experts in each field passed the review for the current COVID-19 sequelae regenerative medical plan after 120 days of review and 3 screenings based on specific and scientific evidence for treatment and clinical research.

As a result, Yesunghoe Trinity Clinic Fukuoka will submit relevant data to the Ministry of Health, Labour and Welfare of Japan, and as soon as necessary administrative procedures are completed, stem cells will be cultured and administered intravenously for patients suffering from shortness of breath, chest pain, and boredom due to COVID-19 sequelae. Nature Cell said that it will practice regenerative medicine. Considering that it usually takes 2 to 3 weeks to administer, full-fledged treatment is expected to begin from late December at the latest. The treatment will take place in Japan, but anyone, including Koreans, can receive this treatment regardless of nationality.

Dr. Jeong-Chan Ra, president of Biostar Stem Cell Research Institute, who developed the treatment, said, "This approval is supported by the numerous regenerative medical records we have developed and conducted.” And “by culturing with a patented technology that has been secured and intravenous administration—good effects are expected through anti-inflammatory action and tissue regeneration action.” Dr. Ra added.

Studies have shown that COVID-19 has recently started to spread in higher numbers around the world. The infection of COVID-19 causes serious sequelae even after being treated. Many patients suffer from brain fog, difficulty breathing and chest pain. According to a publication in the Journal of American Medical Association 2020, 87.4% of COVID-19 patients were identified with at least one after effect, of which there are many symptoms of boredom (53.1%), dyspnea (43.3%), and chest pain (21.7%).

The cause of these sequelae is expected to continue the inflammatory response in the body even after it recovers from COVID-19. It is expected to have a significant impact on treatment through mesenchymal stem cells, which have proven to be effective in cell regeneration and reducing inflammatory cytokines in the body.

In Japan, research on COVID-19 sequelae (Title: COVID-19 Status Survey) has been ongoing since August 1st by the Japanese Society of Respiratory Syndrome (executive responsibility) and the Ministry of Health and Labor (provided research funding). In September, the World Health Organization (WHO) has also addressed serious concerns about the long-term damage caused by COVID-19 and long-term sequelae and changes in the human body.

For more information, contact: Jane Shin (email: jshin@stemcellbio.com)

References
COVID-19 Post-Effective Stem Cell Treatment Process
The fat tissue of patients who have been treated for COVID-19, but those who have sequelae are taken from pre-approved clinics, including Trinity Clinic Fukuoka. Then, the fat tissue is sent to Trinity Clinic Fukuoka after the completion of processing stages at JASC Kyoto Stem Cell Center, Japanese affiliate of Nature Cell. The patient receives 200 million stem cells intravenously three times every 2-4 weeks. The evaluation of treatment is made to check the inflammation reduction and symptom relief through a lung function test, hemolysis of oxygenation, changes in inflammatory level, diagnosis of pain, etc. It also evaluates the safety of stem cell treatment.

About Trinity Clinic Fukuoka and JASC
Trinity Clinic Fukuoka started stem cell treatment for Alzheimer’s disease in 2018, providing treatment to patients with various diseases, including atopic dermatitis, degenerative arthritis, rheumatoid arthritis, and cancer prevention and treatment using immune cells. JASC is in charge of cell culture, which has a Cell Processing Center (CPC) that meets the criteria set out in Article 89 of the Act on Securing the Safety of Regenerative Medicine (Act No. 85 of the 2013 Act), and maintenance and management are carried out in accordance with the Act on Securing the Safety of Regenerative Medicine.

Biostar Stem Cell Research Institute
Biostar was founded in 2005 and made its way in Japan, the United States, Hong Kong and China. Biostar has been focusing on treating incurable diseases, such as autoimmune diseases, Alzheimer’s and Parkinson’s disease. Fat stem cells harvested by Biostar do not cause genetic variation and do not produce toxicity and cancer.

Biostar has established the technology to culture ample cells for treatment just from a small amount of fat tissue. In addition, Biostar has achieved the technology to culture stem cells that can be administered intravenously and the technology to make stem cells younger, as well as 88 registered patents and 62 published papers. After receiving scientific verification of the safety of intravenous stem cells in Japan, a paper was published in the Journal of Stem Cells and Development (Title: Safety of Intravenous Infusion of Human Adipose Tissue-Derived Mesenchymal Stem Cells in Animals and Humans).

In the U.S., clinical approval was received from the FDA in 2017 for intravenous administration of stem cells, which is currently in phase 2b. In the wake of the COVID-19 pandemic era, USFDA approval was received on August 13, 2020 for the clinical trial of other fat stem cells for treatment of patients infected with Coronavirus and is currently under discussion for the study site. In the case of Japan, after the enactment of the Act on Securing the Safety of Renewable Health, medical institutions have been able to provide regenerative medical services to patients after obtaining approval from the Committee for Renewable Health and the Ministry of Health, Labor and Welfare. Biostar has received approval for a total of 10 diseases, starting with autoimmune disease in 2015, including severe hypodermic ischemia, Alzheimer’s disease, and atopic dermatitis.


Current Status of Biostar Stem Cell Research Institute’s Clinical and Treatment Approval
<Chart>

United States
Approval Year Adaptation Path Current Progress
2014 Degenerative arthritis Joint Clinical Trial Phase 2 Completed
2020 Degenerative arthritis Joint Clinical Trial Phase 2b/3a in preparation
2016 Alzheimer’s IV Clinical Trial Phase 1 /2 Completed
2020 Alzheimer’s IV Clinical Trial Phase 2b in Preparation
2020 COVID-19 Pneumonia IV Clinical Trial Phase 1/ 2 in Preparation

Japan
Approval Year Adaptation Path Current Progress
2015 Autoimmune Disease IV Treatment
2015 Degenerative arthritis Joint Treatment
2015 Critical Limb Ischemia IV + Local Treatment
2015 Face Reconstruction & Skin Regeneration Local Treatment
2018 Alzheimer’s IV Clinical Research in Progress
2018 Atopy IV Treatment
2018 Anti- Cancer IV Treatment
2019 Cancer Treatment IV Treatment
2020 Rheumatoid Arthritis IV Treatment
2020 COVID-19 After Effects IV In Preparation for Treatment

Korea
Approval Year Adaptation Path Current Progress
2008 Degenerative arthritis Joint Clinical Trial Phase 1/ 2 Completed
2014 Degenerative arthritis Joint Clinical Trial Phase 2b Completed
2019 Degenerative arthritis Joint Clinical Trial Phase 3 in Progress
2008 Parry-Romberg Syndrome Local Clinical Research Completed
2008 Critical Limb Ischemia Local Clinical Research Completed
2009 Spinal Cord Injury IV Clinical Trial Phase 1 Completed
2012 Spinal Cord Injury IV + Local Clinical Research Completed
2012 Buerger’s disease Local Clinical Trial Phase 1/ 2 Completed
2012 Femoral Head Avascular Necrosis Local Clinical Research Completed
2015 Cerebral Palsy IV Clinical Research Completed
2016 Rotator Muscle Disease Local Clinical Research Completed
2016 Degenerative arthritis (HTO) + Joint Clinical Researcher in Progress
2020 Degenerative arthritis Joint Clinical Researcher in Progress

• A total of 15 permits per hospital in Japan

Jane Shin
Stemcell Bio Inc.
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