Official Title
Single Donor Banked Bone Marrow Mesenchymal Stromal Cells for the Treatment of COVID-19 Induced ARDS: A Non-Blinded Randomized, Controlled Study
Brief Summary

***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.

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

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

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

Acute Respiratory Distress Syndrome

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

Eligibility Criteria

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 (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.

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United States

Houston Methodist Hospital
Houston, Texas, United States

LaQuisa Hill, MD, Principal Investigator
Baylor College of Medicine

Baylor College of Medicine
NCT Number
Mesenchymal stromal cells
Respiratory failure
MeSH Terms
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury