Bone Marrow-Derived Mesenchymal Stem Cell Treatment for Severe Patients With Coronavirus Disease 2019 (COVID-19)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04346368|
Recruitment Status : Unknown
Verified April 2020 by ShiYue Li, Guangzhou Institute of Respiratory Disease.
Recruitment status was: Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : April 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Disease 2019 (COVID-19)||Biological: BM-MSCs Biological: Placebo||Phase 1 Phase 2|
COVID-19 has become a urgent and serious public health event that threatens human life and health globally. No specific pharmacological treatments are available to date for COVID-19.Patients contracting the severe form of the disease constitute approximately 15% of the cases which is characterized by extensive acute inflammation. In these severe cases, there will be rapid respiratory system failure.
MSCs have been employed extensively in cell therapy, which includes a plethora of preclinical research investigations as well as a significant number of clinical trials. Safety and efficacy have been shown in many clinical trials. Previous studies have shown that MSCs could significantly reduce inflammatory cell infiltration in lung tissue, reduce inflammation in lung tissue, and significantly improve lung The structure and function of tissues protect lung tissue from damage.The mechanisms underlying the improvements after MSC infusion in COVID-19 patients also appeared to be the robust antiinflammatory activity of MSCs. Recent studies also showed that intravenous MSC infusion could reduce the overactivation of the immune system and support repair by modulating the lung microenvironment after SARS-CoV-2 infection. MSC therapy inhibiting the overactivation of the immune system and promoting endogenous repair by improving the lung microenvironment after the SARS-CoV-2 infection.
The purpose of this study is to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients With COVID-19.The respiratory function, pulmonary inflammation, clinical symptoms, pulmonary imaging, side effects, immunological characteristics will be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Safety and Efficacy of Intravenous Infusion of Bone Marrow-Derived Mesenchymal Stem Cells in Severe Patients With Coronavirus Disease 2019 (COVID-19): A Phase 1/2 Randomized Controlled Trial|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Bone Marrow-Derived Mesenchymal Stem Cells (BM-MSCs)
Conventional treatment plus BM-MSCs
Participants will receive conventional treatment plus BM-MSCs(1*10E6 /kg body weight intravenously at Day 1).
Placebo Comparator: Placebo
Conventional treatment plus placebo
- Changes of oxygenation index (PaO2/FiO2) [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]Evaluation of pneumonia improvement
- Side effects in the BM-MSCs treatment group [ Time Frame: Baseline through 6 months ]Proportion of participants with treatment-related adverse events
- Clinical outcome [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
- Hospital stay [ Time Frame: Baseline through 6 months ]days of the patients in hospital
- CT Scan [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]Evaluation of pneumonia improvement
- Changes in viral load [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ](deep sputum / pharyngeal swab / nasal swab / anal swab / tear fluid / stomach fluid / feces / blood or alveolar lavage fluid)
- Changes of CD4+, CD8+ cells count and concentration of cytokines [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]Immunological status
- Rate of mortality within 28-days [ Time Frame: From baseline to day 28 ]Marker for efficacy
- Changes of C-reactive protein [ Time Frame: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6. ]Markers of Infection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346368
|Contact: Shiyue Li, MDemail@example.com|
|Contact: Ming Liu, MDfirstname.lastname@example.org|
|Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University|
|Guangzhou, Guangdong, China, 510120|
|Contact: Shiyue Li, MD 86-20-83062885 email@example.com|