On August 10, 2020, hearings for the preparation of phase 1 mesenchymal stem cell therapy and clinical trials for COVID-19 patients were conducted. Stem cell therapy clinical trials on COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS) is a collaboration between the Ministry of Health’s National Institute of Health Research and Development (NIHRD) and Biopharmaceutical Company Daewoong Infion Korea. This collaboration is the implementation of Indonesia and South Korea Health Cooperation signed in Bogor, on November 9, 2017. Collaboration on mesenchymal stem cell therapy clinical trials was one of the agendas discussed during the 2nd virtual Joint Working Group (JWG) RI-Korea on August 6, 2020. The Indonesian Ministry of Health and the Korean Ministry of Health supports the working collaboration between governments and health industries in both countries.
During the hearing, a symbolic signing of Mesenchymal Stem Cell Therapy Clinical Trials Collaboration MoU between Head of Research and Development of Health Resources and Services and Biopharmaceutical Company Daewoong Infion Korea was held. The signing was witnessed by Acting Head of NIHRD and President Director of PT Daewoong Infion, MTA Head Committee, Medicine Registration Indonesian FDA Directorate, NIHRD Secretariat, Health Services Secretariate of the Directorate General, Reference Health Services Directorate and Acting Head of KSLN Bureau.
The collaboration was done to accelerate the discovery of effective therapies for COVID-19, by conducting phase 1 Mesenchymal Stem Cell (MSC) therapy clinical trials otherwise known in Indonesia as Mesenchymal Stem Cell. Stem cell therapy is not a new therapy, known as “modern medicine,” this therapy is hoped to resolve Acute Respiratory Distress Syndrome (ARDS) which some COVID-19 suffer patients from. Stem Cell itself does not work directly to kill viruses, but functions as an immunomodulator to suppress the production of reactive substances, causing hyper inflammation and damage lung tissue. Additionally, Mesenchymal Stem Cell has antifibrotic effects that can replace fibrotic lung tissues or damaged by hyper inflammation.
According to research conducted in other countries published in systematic reviews and meta-analysis, Mesenchymal Stem Cell was determined safe, with minimal side effects, and proven to lower death rate and improve lung function in patients with Acute Respiratory Distress Syndrome (ARDS). Mesenchymal Stem Cell products have gone through pre-clinical trials, proven to be safe and potent.
Acting Head of NIHRD, dr. Slamet, MHP, conveyed his support for the preparation for clinical trials. NIHRD sees excellent potential in Mesenchymal Stem Cell as therapy for COVID-19 patients. The collaboration is expected to accelerate the discovery of an effective treatment for COVID-19 patients.
Head of Research and Development of Health Resources and Services of the Ministry of Health’s NIHRD, Dr. dr. Irmansyah, Sp.KJ, as a research coordinator, informed that the research is conducted in one of the Ministry of Health’s referral hospitals. Irmansyah hopes for the support and cooperation of all parties involved in the study, from preparation to the final stage of attaining research results and publication in a reputable scientific journal.
President Director of dr. Wahidin Sudirohusodo Makassar Hospital, Dr. dr. Khalid Saleh, Sp.PD-KKV, FINASIM, M.Kes, conveys dr. Wahidin Sudirohusodo Makassar Hospital’s commitment to conducting mesenchymal stem cell therapy clinical trials on COVID-19 patients with ASRD, from beginning to the final stage of attaining results of clinical trials.
Furthermore, the Ministry of Health also welcomed the proposed collaboration with PT Daewoong Infion regarding clinical trials for COVID-19 drug candidates, of which Daewoong has completed phase 1 clinical trials in Korea and India.
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drg. Widyawati, MKM