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 versus controls can help to treat respiratory infections caused by SARS-CoV-2.
Earlier, a healthy donor provided blood cells to generate MSCs. These cells were grown and frozen for later use. Before being treated, the patient will receive a series of standard medical tests: - Physical exam and history - SARS-CoV-2 test - Blood tests - Chest X-ray or chest CT Scan - A urine pregnancy test, when applicable The patient will be randomly assigned to a study group. We'll use a computer to put the patient into study group A (study drug) or group B (control) by chance (randomized). Patients randomized to the control group, will receive the standard treatment for their respiratory infection. These tests are done to assess the patient's eligibility to receive the cells. On the day that the patient is scheduled to receive the cells they will be pre-medicated with Benadryl and Tylenol. The patient will then receive a single intravenous (into the vein) infusion of 2 x 10^6 cells/kg of MSCs. The patient will be monitored closely for two hours after the infusion. The patient will receive standard medical tests when getting the infusion and afterwards. As part of the research study, the patient will be evaluated daily for 7 days and then weekly at weeks 2, 3, and 4. The evaluations that will be done at these visits include: - Physical exam and history - SARS-CoV-2 test - Blood tests - Chest X-ray or chest CT Scan
Biological: Mesenchymal Stromal Cells
Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs.
Other Name: MSCs
Other: Supportive Care
Patients will receive supportive care per their treating physician
1) 18 years or older 2) Confirmed SARS-CoV2 infection real-time reverse transcription
polymerase chain reaction (RT-PCR) assay 3) Moderate to severe acute respiratory distress
syndrome (ARDS), based on the degree of impairment of oxygenation as defined by the ratio
of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). Based on the Berlin
criteria noted below. 1. Moderate ARDS: PaO2/FiO2 100-200 mmHg, on invasive or noninvasive mechanical ventilation settings that include EEP ≥5 cm H2O 2. Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O
AND - Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules. - Respiratory failure not fully explained by cardiac failure or fluid overload.
Exclusion Criteria: 1. Currently receiving extracorporeal membrane oxygenation (ECMO) 2. Severe chronic respiratory disease requiring use of home oxygen 3. Pregnant or lactating 4. Known hypersensitivity to dimethyl sulfoxide (DMSO) 5. Unstable hemodynamics (ventricular tachycardia or fibrillation) 6. Uncontrolled bacterial or fungal co-infection 7. Any end-stage organ disease or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment 8. Inability to obtain informed consent (from patient or legally appropriate proxy) 9. Presence of any contraindication to receiving prophylactic low dose unfractionated or low molecular weight heparin.
Houston Methodist Hospital
Houston, Texas, 77030
Investigator: LaQuisa Hill, MD
LaQuisa Hill, MD
LaQuisa Hill, MD
Baylor College of Medicine