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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1267-1200 | Other Identifier | UTN - WHO International Clinical Trials Registry Platform | |
| 31935420.7.1001.0020 | Other Identifier | CAAE - Certificado de Apresentação para Apreciação Ética |
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No patient could be included because there was a decrease in the number of patients with complications due to COVID-19. Also, a Brazilian government agency approved this clinical trial, and the project execution period ended in March 2023.
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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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The purpose of this study is evaluate the feasibility, safety and potential efficacy of an advanced cell therapy product for the treatment of patients with SARS-CoV-2 pneumonia.
Forty patients with COVID-19 will receive an intravenous infusion of one dose of 1.000.000 umbilical cord mesenchymal cells per kilo of the patient. Twenty patients will receive a placebo (Ringer's lactate solution, albumin and heparin). Conventional treatment will be performed together with the infusion of cells, during the study period. The evaluation times will be at pre-infusion, 6 and 24 hours, days 5 and 28, 3 and 6 months. The patient exams performed: serology, biochemistry, blood count and blood gas analysis, metabolomics/proteomics, antibody evaluation, electrocardiogram, CT-scan and X-ray, cytokines, viral load, cytometry, and clinical evaluation. The patients will be evaluated all the time, during hospitalization period, to assess adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patient: Intravenous infusion of single-dose of Mesenchymal stem cells (MSCs) |
|
| Placebo | Placebo Comparator | Intravenous infusion of single-dose of Ringer's lactate, albumin and heparin solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cell | Biological | Administration of advanced cell product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of intravenously infused UCT-MSC suspension | The primary expected outcome is the safety and tolerability of using intravenously infused UTC-MSC suspension in patients with pneumonia caused by SARS-CoV-2. This outcome will be evaluated by recording adverse events that must be reported throughout the study period. | After first cell infusion until the end of study. The clinical follow-up of patients will be one year after the transplant. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function test to evaluate the improvement of respiratory function | Evaluation of lung function. | Pre-infusion, on days 5 and 28, 3 and 6 months. |
| Radiography to evaluate the improvement of respiratory function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulo R Brofman, phD | Pontifícia Universidade Católica do Paraná | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paulo Roberto Slud Brofman | Curitiba | Paraná | 80215200 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35313959 | Result | Rebelatto CLK, Senegaglia AC, Franck CL, Daga DR, Shigunov P, Stimamiglio MA, Marsaro DB, Schaidt B, Micosky A, de Azambuja AP, Leitao CA, Petterle RR, Jamur VR, Vaz IM, Mallmann AP, Carraro Junior H, Ditzel E, Brofman PRS, Correa A. Safety and long-term improvement of mesenchymal stromal cell infusion in critically COVID-19 patients: a randomized clinical trial. Stem Cell Res Ther. 2022 Mar 21;13(1):122. doi: 10.1186/s13287-022-02796-1. | |
| 34074163 |
| Label | URL |
|---|---|
| UC-MSCs infusion is safe and can play an important role as an adjunctive therapy, both in the early stages, preventing severe complications and in the chronic phase with postacute sequelae reduction in critically ill COVID-19 patients. | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo |
| Other |
Ringer's lactate, albumin and heparin solution |
|
Evaluation of pulmonary function using breathing chest radiography. Assessment of peripheral opacities, interstitial and airspace opacities, diffuse airspace opacities, interstitial opacities, lobar consolidation, atelectasis, cavities, pulmonary cysts, and emphysema.
| Pre-infusion, on days 5 and 28, 3 and 6 months. |
| 6-minute walk to evaluate the improvement of respiratory function | Distance covered by the patient in a period of 6 minutes. | Pre-infusion, on days 5 and 28, 3 and 6 months. |
| Decrease on days of non-invasive mechanical ventilation | Analysis of ventilatory parameters and arterial blood gas analysis. | Six hours after infusion, days 1, 5 and 28, 3 and 6 months. |
| Biochemical tests to evaluate the improvement of laboratory parameters | D-dimer, C-reactive protein, erythrocyte sedimentation rate, ferritin, creatine, urea, saline, potassium, bilirubin, total protein and fractions, albumin, globulin, oxalacetic transaminase, pyruvic transaminase, lactate dehydrogenase, creatine phosphokinase, troponin I, coagulogram. | Pre-infusion, on days 1, 5 and 28, 3 and 6 months. |
| Blood count to evaluate the improvement of laboratory parameters | Red blood cells, hemoglobin, hematocrit, total leukocytes, basophil, eosinophil, neutrophil, lymphocytes, monocytes, platelets. | Pre-infusion, on days 1, 5 and 28, 3 and 6 months. |
| Viral load to evaluate the improvement of laboratory parameters | Expression of the RpRd gene. | Pre-infusion, on days 1, 5 and 28, 3 and 6 months. |
| Cytokine dosage to evaluate inflammatory parameters | Granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin (IL) -2, IL-6, IL-7, IL-8, tumor necrosis factor (TNF) α, monocyte chemoattractant protein-1 (MCP1/CCL2) and macrophage inflammatory protein 1-alpha (MIP1a/CCL3). | Pre-infusion, on days 1, 5 and 28, 3 and 6 months. |
| Decrease in hospital stay | Evaluation of hospitalization days. | From admission to discharge, or a maximum of 6 months. |
| Computed tomography score to evaluate the improvement of pulmonary function | Chest computed tomography evaluation will analyze the following characteristics: ground glass opacities, linear opacities, consolidation, interlobular septal thickening, crazy-paving pattern, subpleural lines, bronchial wall thickening, lymph node enlargement and pleural effusion. Lesions will quantify by assigning a score to all abnormal areas involved. Each lobe will assigned a score of 0 (0% involvement), 1 (1-25% involvement), 2 (26-50% involvement), 3 (51-75% involvement) or 4 (76%-100% involvement). The total score will be the sum of all lobes, ranging from 0 to 25. | Pre-infusion, on days 5 and 28, 3 and 6 months. |
| Reduction in the percentage of intubated patients | Clinical evaluation of patients. | After first cell infusion until six months after the transplant. |
| Decrease in mortality | Evaluation of the number of patients who died during the study. | After first cell infusion until the end of study. The clinical follow-up of patients will be six months after the transplant. |
| Result |
| Senegaglia AC, Rebelatto CLK, Franck CL, Lima JS, Boldrini-Leite LM, Daga DR, Leitao CA, Shigunov P, de Azambuja AP, Bana E, Marsaro DB, Schaidt B, Micosky A, Jamur VR, Schluga Y, Vaz IM, Ribeiro LL, Correa A, Brofman EPRS. Combined Use of Tocilizumab and Mesenchymal Stromal Cells in the Treatment of Severe Covid-19: Case Report. Cell Transplant. 2021 Jan-Dec;30:9636897211021008. doi: 10.1177/09636897211021008. |
| The combination of tocilizumab and UC-MSC proved to be safe, with no adverse effects, and the results of this case report prove to be a promising alternative in the treatment of patients with severe acute respiratory syndrome due to SARS-CoV-2. | View source |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |