Covid19 — Expanded Access to Zofin for Patients With COVID-19
Citation(s)
Abraham A, Krasnodembskaya A Mesenchymal stem cell-derived extracellular vesicles for the treatment of acute respiratory distress syndrome. Stem Cells Transl Med. 2020 Jan;9(1):28-38. doi: 10.1002/sctm.19-0205. Epub 2019 Oct 24.
Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.
Arabia SC Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells. 2020.
Bagno L, Hatzistergos KE, Balkan W, Hare JM Mesenchymal Stem Cell-Based Therapy for Cardiovascular Disease: Progress and Challenges. Mol Ther. 2018 Jul 5;26(7):1610-1623. doi: 10.1016/j.ymthe.2018.05.009. Epub 2018 May 25.
Center AM Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19). 2020
Center MDAC and Foundation K Mesenchymal Stem Cells (MSCs) for Treatment of Acute Respiratory Distress Syndrome (ARD) in Patients With Malignancies. 2017
Center SPHC Efficacy and Safety of Hydroxychloroquine for Treatment of Pneumonia Caused by 2019-nCoV ( HC-nCoV ). 2020
Chan JF, Lau SK, Woo PC The emerging novel Middle East respiratory syndrome coronavirus: the "knowns" and "unknowns". J Formos Med Assoc. 2013 Jul;112(7):372-81. doi: 10.1016/j.jfma.2013.05.010. Epub 2013 Jul 21.
Chiodini P, Arenare L, Piccirillo MC, Perrone F, Gallo C A phase 2, open label, multicenter, single arm study of tocilizumab on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia (TOCIVID-19 trial): Statistical analysis plan. Contemp Clin Trials Commun. 2020 Dec;20:100665. doi: 10.1016/j.conctc.2020.100665. Epub 2020 Oct 7.
Clinic M Mesenchymal Stem Cell Therapy for Lung Rejection. 2014
Clinic M Mesenchymal Stem Cells in the Treatment of Subjects With Advance Chronic Obstructive Pulmonary Disease (COPD). 2020.
Da Sacco S, De Filippo RE, Perin L Amniotic fluid as a source of pluripotent and multipotent stem cells for organ regeneration. Curr Opin Organ Transplant. 2011 Feb;16(1):101-5. doi: 10.1097/MOT.0b013e3283424f6e.
Hospital B, CELL V, GENE ENGINEERING CORP L, China, Wuhan Huoshenshan Hospital W, China, Hospital TH, Hospital STPs, Fifth Affiliated Hospital SY-SU, Wuhan Union Hospital C and Hospital WC. Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19). 2020
Hospital B, Innovative Precision Medicine Group H, China , Wuhan Huoshenshan Hospital W, China, Hospital TH, CELL V, GENE ENGINEERING CORP. L, China, Hospital STPs and Fifth Affiliated Hospital SY-SU. Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With 2019 Novel Coronavirus. 2020.
Hospital B Treatment and Prevention of Traditional Chinese Medicines (TCMs) on 2019-nCoV Infection. 2020.
Hospital BCY Efficacy and Safety of Corticosteroids in COVID-19. 2020
Hospital BY, Shenyang Tonglian Group Co L, Medicine Io, Biotechnology CAoMS, Hospital HC, University SP, University FAHoCM, University TSAHoHM, City NPsHoF, College FAHBM, University RHoW, Shenyang Tspsho and Hospital NC. The Clinical Study of Carrimycin on Treatment Patients With COVID-19. 2020
Hospital T-D Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia. 2020
Hospital T A Pilot Study of Sildenafil in COVID-19. 2020.
Hospital T A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia. 2020
Hospital T A Prospective/Retrospective,Randomized Controlled Clinical Study of Interferon Atomization in the 2019-nCoV Pneumonia. 2020
Hospital T A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia. 2020
Hospital T Efficacy and Safety of IFN-a2ß in the Treatment of Novel Coronavirus Patients. 2020.
Hospital T The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19. 2020
Hospital T The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia. 2020.
Hospital TPC and Institute MMR A Study to Evaluate the Potential Role of Mesenchymal Stem Cells in the Treatment of Idiopathic Pulmonary Fibrosis. 2010.
Karantalis V, Schulman IH, Balkan W, Hare JM Allogeneic cell therapy: a new paradigm in therapeutics. Circ Res. 2015 Jan 2;116(1):12-5. doi: 10.1161/CIRCRESAHA.114.305495. No abstract available.
Li X, Yue S, Luo Z Mesenchymal stem cells in idiopathic pulmonary fibrosis. Oncotarget. 2017 May 23;8(60):102600-102616. doi: 10.18632/oncotarget.18126. eCollection 2017 Nov 24.
Ling L, Nurcombe V, Cool SM Wnt signaling controls the fate of mesenchymal stem cells. Gene. 2009 Mar 15;433(1-2):1-7. doi: 10.1016/j.gene.2008.12.008. Epub 2008 Dec 24.
Ltd JQPC. Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe). 2020
Ltd JQPC. Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia. 2020
Ltd MC. PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants. 2018
Luo H, Tang QL, Shang YX, Liang SB, Yang M, Robinson N, Liu JP Can Chinese Medicine Be Used for Prevention of Corona Virus Disease 2019 (COVID-19)? A Review of Historical Classics, Research Evidence and Current Prevention Programs. Chin J Integr Med. 2020 Apr;26(4):243-250. doi: 10.1007/s11655-020-3192-6. Epub 2020 Feb 17.
Mesoblast I and Mesoblast L PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). 2008.
Minnesota Uo Post-exposure Prophylaxis for SARS-Coronavirus-2. 2020.
Minnesota Uo Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization. 2020.
Minnesota Uo Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization. 2020.
Pan Y, Guan H, Zhou S, Wang Y, Li Q, Zhu T, Hu Q, Xia L Initial CT findings and temporal changes in patients with the novel coronavirus pneumonia (2019-nCoV): a study of 63 patients in Wuhan, China. Eur Radiol. 2020 Jun;30(6):3306-3309. doi: 10.1007/s00330-020-06731-x. Epub 2020 Feb 13.
Peng Z and Hospital Z Vitamin C Infusion for the Treatment of Severe 2019-nCoV Infected Pneumonia. 2020.
Peng Z, Ltd TBTC and Hospital Z Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus(nCOV) Pneumonia. 2020
Pharmaceuticals R and Sanofi Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19. 2020
Prockop DJ, Oh JY Mesenchymal stem/stromal cells (MSCs): role as guardians of inflammation. Mol Ther. 2012 Jan;20(1):14-20. doi: 10.1038/mt.2011.211. Epub 2011 Oct 18.
Pulmotect I The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID- 19 in Adults Positive for SARS-CoV-2 Infection. 2020
Pulmotect I The Use PUL-042 Inhalation Solution to Prevent COVID-19 in Adults Exposed to SARS-CoV-2. 2020
QU J and Hospital R Clinical Study of Arbidol Hydrochloride Tablets in the Treatment of Pneumonia Caused by Novel Coronavirus. 2020
Sciences CAoCM Yinhu Qingwen Decoction for the Treatment of Mild Common CoVID-19. 2020.
Sciences G Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS- 5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment. 2020.
Sciences G Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS- 5734™) in Participants With Severe Coronavirus Disease (COVID-19). 2020
Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24.
Shi Y, Wang Y, Li Q, Liu K, Hou J, Shao C, Wang Y Immunoregulatory mechanisms of mesenchymal stem and stromal cells in inflammatory diseases. Nat Rev Nephrol. 2018 Aug;14(8):493-507. doi: 10.1038/s41581-018-0023-5.
University SAHoWM and WanBangDe Pharmaceutical Group Co L. Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19). 2020
University SY-s Human Umbilical Cord Mesenchymal Stem Cells (MSCs) Therapy in ARDS. 2018.
Wuhan Union Hospital C Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients. 2020
Zumla A, Chan JF, Azhar EI, Hui DS, Yuen KY Coronaviruses - drug discovery and therapeutic options. Nat Rev Drug Discov. 2016 May;15(5):327-47. doi: 10.1038/nrd.2015.37. Epub 2016 Feb 12.
Expanded Access to Zofin for the Treatment of Patients With Mild to Moderate COVID-19 Due to SARS-Cov-2 for Outpatient and Inpatient Population
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
