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Purpose

***At this time, we are only enrolling at Houston Methodist Hospital (HMH)/Baylor College of Medicine (BCM) and are not shipping cells outside of BCM/HMH.*** 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 18 years or older 2. Confirmed SARS-CoV2 infection real-time reverse transcription polymerase chain reaction (RT-PCR) assay 3. Moderate OR severe 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): 1. Moderate ARDS: PaO2/FiO2 100-200 mmHg OR 2. Severe ARDS: PaO2/FiO2 ≤100 mmHg 4. If on invasive or noninvasive (BiPAP) mechanical ventilator, PEEP ≥5 cm H2O 5. Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.

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 as deemed by the treating physician/investigator including but not limited to unstable, ventricular tachycardia or new cardiac arrythmia requiring cardioversion. 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. 10. Respiratory failure not fully explained by cardiac failure or fluid overload.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Safety Run In 		The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care.
  • 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 names:
    • MSCs
Experimental
Mesenchymal stromal cells 		Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion.
  • 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 names:
    • MSCs
Other
Control Group 		Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians.
  • Other: Supportive Care
    Patients will receive supportive care per their treating physician

Recruiting Locations

More Details

NCT ID
NCT04345601
Status
Completed
Sponsor
Baylor College of Medicine

Detailed Description

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: These tests are done to assess the patient's eligibility to receive the cells. - 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. 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 an intravenous (into the vein) infusion of 1 x 10^8 cells/kg of MSCs. The patient will be monitored closely for two hours after the infusion. The patient will receive a second infusion at the same dose within 3-5 days of the initial infusion (at the discretion of the investigator) if there is no improvement in respiratory parameters or if there is a worsening of Acute respiratory distress syndrome (ARDS). The patient will receive standard medical tests when getting the infusion(s) 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.