Alok Sharma1,2, Rohit Kulkarni3, Hemangi Sane4, Nilkanth Awad5, Abhijit Bopardikar3, Anagha Joshi6, Sujata Baweja7, Mohan Joshi8, Chandra Vishwanathan3, Nandini Gokulchandran2, Prerna Badhe9, Mazhar Khan1, Amruta Paranjape4, Pooja Kulkarni4, Arjun K Methal4. 1. Department of Neurosurgery, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India. 2. Department of Medical Services and Clinical Research, NeuroGen Brain & Spine Institute Navi Mumbai, Maharashtra, India. 3. ReeLabs Pvt. Ltd Mumbai, Maharashtra, India. 4. Department of Research & Development, NeuroGen Brain & Spine Institute Navi Mumbai, Maharashtra, India. 5. Department of Pulmonary Medicine, LTMG Hospital and LTM Medical College Sion, Mumbai, Maharashtra, India. 6. Department of Radiology, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India. 7. Department of Microbiology, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India. 8. Dean, LTMG Hospital and LTM Medical College Mumbai, Maharashtra, India. 9. Department of Regenerative Laboratory, NeuroGen Brain and Spine Institute Seawoods, Navi Maharashtra, India.
Abstract
OBJECTIVE: Mesenchymal stem cells can serve as a therapeutic option for COVID-19. Their immunomodulatory and anti-inflammatory properties can regulate the exaggerated inflammatory response and promote recovery of lung damage. METHOD: Phase-1, single-centre open-label, prospective clinical trial was conducted to evaluate the safety and efficacy of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in moderate COVID-19. The study was done in 2 stages with total 20 patients. Herein, the results of stage 1 including first 10 patients receiving 100 million cells on day 1 and 4 with a follow up of 6 months have been discussed. RESULTS: No adverse events were recorded immediately after the administration of MSCs or on follow up. There was no deterioration observed in clinical, laboratory and radiological parameters. All symptoms of the study group resolved within 10 days. Levels of inflammatory biomarkers such as NLR, CRP, IL6, ferritin and D-dimer improved in all patients after intervention along with improved oxygenation demonstrated by improvement in the SpO2/FiO2 ratio and PaO2/FiO2 ratio. None of the patients progressed to severe stage. 9 out of 10 patients were discharged within 9 days of their admission. Improvements were noted in chest x-ray and chest CT scan scores at day 7 in most patients. No post-covid fibrosis was observed on chest CT 28 days after intervention and Chest X ray after 6 months of the intervention. CONCLUSION: Administration of 100 million mesenchymal stem cells in combination with standard treatment was found to be safe and resulted in prevention of the cytokine storm, halting of the disease progression and acceleration of recovery in moderate COVID-19. This clinical trial has been registered with the Clinical Trial Registry- India (CTRI) as CTRI/2020/08/027043. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43175. AJSC
OBJECTIVE: Mesenchymal stem cells can serve as a therapeutic option for COVID-19. Their immunomodulatory and anti-inflammatory properties can regulate the exaggerated inflammatory response and promote recovery of lung damage. METHOD: Phase-1, single-centre open-label, prospective clinical trial was conducted to evaluate the safety and efficacy of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in moderate COVID-19. The study was done in 2 stages with total 20 patients. Herein, the results of stage 1 including first 10 patients receiving 100 million cells on day 1 and 4 with a follow up of 6 months have been discussed. RESULTS: No adverse events were recorded immediately after the administration of MSCs or on follow up. There was no deterioration observed in clinical, laboratory and radiological parameters. All symptoms of the study group resolved within 10 days. Levels of inflammatory biomarkers such as NLR, CRP, IL6, ferritin and D-dimer improved in all patients after intervention along with improved oxygenation demonstrated by improvement in the SpO2/FiO2 ratio and PaO2/FiO2 ratio. None of the patients progressed to severe stage. 9 out of 10 patients were discharged within 9 days of their admission. Improvements were noted in chest x-ray and chest CT scan scores at day 7 in most patients. No post-covid fibrosis was observed on chest CT 28 days after intervention and Chest X ray after 6 months of the intervention. CONCLUSION: Administration of 100 million mesenchymal stem cells in combination with standard treatment was found to be safe and resulted in prevention of the cytokine storm, halting of the disease progression and acceleration of recovery in moderate COVID-19. This clinical trial has been registered with the Clinical Trial Registry- India (CTRI) as CTRI/2020/08/027043. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43175. AJSC
Authors: D F McAuley; G F Curley; U I Hamid; J G Laffey; J Abbott; D H McKenna; X Fang; M A Matthay; J W Lee Journal: Am J Physiol Lung Cell Mol Physiol Date: 2014-02-14 Impact factor: 5.464
Authors: Mark W Tenforde; Sara S Kim; Christopher J Lindsell; Erica Billig Rose; Nathan I Shapiro; D Clark Files; Kevin W Gibbs; Heidi L Erickson; Jay S Steingrub; Howard A Smithline; Michelle N Gong; Michael S Aboodi; Matthew C Exline; Daniel J Henning; Jennifer G Wilson; Akram Khan; Nida Qadir; Samuel M Brown; Ithan D Peltan; Todd W Rice; David N Hager; Adit A Ginde; William B Stubblefield; Manish M Patel; Wesley H Self; Leora R Feldstein Journal: MMWR Morb Mortal Wkly Rep Date: 2020-07-31 Impact factor: 17.586