Covid 19 Research using Clinical Trials (Home Page)
Mesenchymal Stromal CellsWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug919 | Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19) Wiki | 0.58 |
| drug166 | Biospecimen collection Wiki | 0.58 |
| drug154 | Biological collection (patients co infected HIV Sras-CoV-2) Wiki | 0.58 |
| drug98 | Auto-questionnaires (patients co infected HIV Sras-CoV-2) Wiki | 0.58 |
| drug850 | Placebo Wiki | 0.05 |
There are 3 clinical trials
Clinical Trials
1 Single Donor Banked Bone Marrow Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure: A Pilot Study
This is a study for patients who have respiratory infection caused by SARS-CoV-2 that have not gotten better. Because there is no standard treatment for this infection, patients are being asked to volunteer for a gene transfer research study using mesenchymal stem cells (MSCs). Stem cells are cells that do not yet have a specific function in the body. Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown from bone marrow (the spongy tissue inside of bones). Stem cells can develop into other types of more mature (specific) cells, such as blood and muscle cells. The purpose of this study is to see if MSCs can help to treat respiratory infections caused by SARS-CoV-2.
NCT04345601 Sars-CoV2 Acute Respiratory Distress Syndrome COVID-19 Genetic: Mesenchymal Stromal Cells MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury
Primary Outcomes
Description: Incidence of unexpected adverse events within 28 days following infusion of MSCs. Adverse events are graded by CTCAE version 5.
Measure: Incidence of unexpected adverse events Time: 28 days post cell infusionDescription: Proportion of patients with improved oxygenation, defined as oxygen saturation >=93% on room air or no more than 5L of supplemental oxygen.
Measure: Improved oxygen saturations ≥93% Time: Within 7 days of cell infusionSecondary Outcomes
Description: Decrease in oxygen supplementation assessed by FiO2 % by non-invasive or invasive interventions from baseline to day 7.
Measure: Decrease in oxygen supplementation by non-invasive or invasive interventions Time: Within 7 days of cell infusionDescription: Frequency of patients who progress using mechanical ventilation or ECMO
Measure: Frequency of progression to mechanical ventilation or ECMO Time: 28 days post cell infusionDescription: Days on mechanical ventilation
Measure: Duration of mechanical ventilation Time: Days from time of intubation to extubation or date of death, whichever occurs first, assessed up to 28 days post-infusionDescription: Days of ICU stay
Measure: Duration of ICU stay Time: Days from admission to ICU to discharge from ICU or date of death, whichever occurs first, assessed up to 28 days post-infusionDescription: Days of hospital stay
Measure: Duration of hospital stay Time: Days from admission to hospital to discharge from hospital or date of death, whichever occurs first, assessed up to 28 days post-infusionDescription: Mortality rate from all causes at day 28
Measure: All-cause mortality at day 28 Time: 28 days post cell infusion2 Double Blind, Placebo-controlled, Phase II Trial to Evaluate Safety and Efficacy of Allogenic Mesenchymal Stromal Cells MSV_allo for Treatment of Acute Respiratory Failure in Patients With COVID-19 Pneumonia (COVID_MSV)
Novel coronavirus COVID-19 has become a health emergency around the world. Since first patients were detected in Wuhan China, in December 2019, COVID-19 has spread quickly worldwide, being a severe threat to public health. Fever, dry cough, shortness of breath and breathing distress are the main characteristics of COVID-19 infection. Some patients develop overwhelming lung inflammation and acute respiratory failure, for which there is no specific therapy. Therefore, safe and effective treatment for COVID-19 pneumonia is utterly necessary, mainly in critical cases. Mesenchymal stem cells (MSCs) have been widely used in the immune-mediated inflammatory diseases. MSCs can regulate both innate and adaptive immunity by suppressing the proliferation, differentiation and activation of different cells. These immunomodulatory properties of MSCs support performance of the phase I/II, placebo- controlled, randomized MSCs for treatment of severe COVID-19 pneumonia.
NCT04361942 COVID-19 Pneumonia Biological: Mesenchymal Stromal Cells Other: Placebo MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: Index of therapy success to preserve Intensive Care Hospitalization space
Measure: Proportion of patients who have achieved withdrawal of invasive mechanical ventilation Time: 0-7 days
Description: To measure global success
Measure: Rate of mortality Time: 28 days
Secondary Outcomes
Description: Index based in the 4 most relevant symptoms and signs: fever, shortness of bread, %Hemoglobin Saturation and PaO2 / FiO2
Measure: Proportion of patients who have achieved clinical response Time: 0-7days
Description: Evaluation of pneumonia changes
Measure: Proportion of patients who have achieved radiological responses Time: 0-28 days
Other Outcomes
Description: Haemogram and cell subpopulations
Measure: Blood white cell counts and their subpopulations. Time: 0-180 days
Description: Lymphocyte profiles, CD3, CD19, CD16+CD56, CD4/CD8, Tregs
Measure: Cellular markers of inflammation Time: 0-180 days
Description: IL-10, IL-6, IP-10, TNF-alpha
Measure: Cytokines and chemokines in peripheral blood Time: 0-180 days
3 Cellular Immuno-Therapy for COVID-19 ARDS (CIRCA-19) the Vanguard Study
Primary Outcomes
Description: Index of therapy success to preserve Intensive Care Hospitalization space
Measure: Proportion of patients who have achieved withdrawal of invasive mechanical ventilation Time: 0-7 daysDescription: To measure global success
Measure: Rate of mortality Time: 28 daysSecondary Outcomes
Description: Index based in the 4 most relevant symptoms and signs: fever, shortness of bread, %Hemoglobin Saturation and PaO2 / FiO2
Measure: Proportion of patients who have achieved clinical response Time: 0-7daysDescription: Evaluation of pneumonia changes
Measure: Proportion of patients who have achieved radiological responses Time: 0-28 daysOther Outcomes
Description: Haemogram and cell subpopulations
Measure: Blood white cell counts and their subpopulations. Time: 0-180 daysDescription: Lymphocyte profiles, CD3, CD19, CD16+CD56, CD4/CD8, Tregs
Measure: Cellular markers of inflammation Time: 0-180 daysDescription: IL-10, IL-6, IP-10, TNF-alpha
Measure: Cytokines and chemokines in peripheral blood Time: 0-180 daysThe clinical picture of the novel corona virus 2 (SARS-CoV-2) disease (COVID-19) is rapidly evolving. Although infections may be mild, up to 25% of all patients admitted to hospital require admission to the intensive care unit, and as many as 40% will progress to develop severe problems breathing due to the acute respiratory distress syndrome (ARDS). ARDS often requires mechanical ventilation, with a 50% risk of mortality. Researchers at the Ottawa Hospital Research Institute (OHRI) have been studying the potential therapeutic role of mesenchymal stromal/stem cells, or MSCs, for the treatment of ARDS for over a decade. This has led to the world's first clinical trial using MSC therapy for patients with severe infections (sepsis) which is often associated with ARDS (NCT02421484). This trial demonstrated tolerability, and potential signs of efficacy. In addition, the investigators have established expertise in producing clinical-grade MSCs and have received approval from Health Canada for the use of MSCs in three different clinical studies. The investigators propose a Phase 1, open label, dose-escalating and safety trial using a 3+3+3 design to determine the safety, and maximum feasible tolerated dose of repeated delivery of Bone Marrow (BM)-MSCs intravenously. This will take advantage of a limited supply of screened BM-MSCs lines which are available now in the GMP facility and will allow to have product ready to deliver to the first patient within weeks. The investigators will enroll up to 9 patients; each receiving repeated unit doses of BM-MSCs delivered by IV infusion on each of 3 consecutive days (24±4 hours apart) according to the following dose-escalation schedule (3 patients per dose panel): (i) Panel 1: 25 million cells/unit dose (cumulative dose: 75 million MSCs), (ii) Panel 2: 50 million cells/unit dose (cumulative dose: 150 million MSCs), (iii) Panel 3: up to 90 million cells/unit dose (cumulative dose: up to 270 million MSCs).
NCT04400032 Acute Respiratory Distress Syndrome Covid19 Biological: Mesenchymal Stromal Cells MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome
Primary Outcomes
Description: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 to determine the maximum feasible tolerated dose (MFTD) of BM-MSCs given to patients with COVID-19
Measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 Time: At time of infusion until one year post-infusionSecondary Outcomes
Description: Number of Participants alive by Day 28
Measure: Number of Participants alive by Day 28 Time: Day 28Description: Number of Participants with ventilator-free Days by Day 28
Measure: Number of Participants with ventilator-free Days by Day 28 Time: Day 28