Official Title
Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)
Brief Summary

The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).

Corona Virus Infection
ARDS, Human
Acute Respiratory Distress Syndrome

Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.
UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.
UC-MSCs Group

Other: Vehicle + Heparin along with best supportive care
Best supportive care treatment per the treating hospital protocol.
Control Group

Eligibility Criteria

Inclusion Criteria:

Patients >/= 18 years old diagnosed with COVID-19 (as evaluated by PCR test confirming
infection with SARS-CoV-2) will be eligible for inclusion if they meet all of the below
criteria. Inclusion criteria must all be present within a 24-hour time period at the time
of enrollment: 1. Patient currently hospitalized 2. Aged ≥ 18 years 3. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent 4. Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening 5. PaO2/FiO2 ratio < 300 mmHg 6. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan 7. Hypoxemia requiring an increase in the fraction of inspired oxygen (FiO2) of ≥ 20% AND an increase in positive end-expiratory airway pressure (PEEP) level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation

Exclusion Criteria: 1. PaO2/FiO2 ≥ 300 at the time of enrollment 2. A previous MSC infusion not related to this trial 3. History of Pulmonary Hypertension (WHO Class III/IV) 4. History of left atrial hypertension or decompensated left heart failure. 5. Pregnant or lactating patient 6. Unstable arrhythmia 7. Patients with previous lung transplant 8. Patients currently receiving chronic dialysis 9. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)

10. Presence of any active malignancy (except non-melanoma skin cancer)

11. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%

12. Moderate to severe liver disease (AST and ALT >5 X ULN)

13. Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen

14. Baseline QT prolongation

15. Moribund patient not expected to survive > 24 hours

Eligibility Gender
Eligibility Age
Minimum: 18 Years
United States

Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, 33136

Camillo Ricordi, MD
Principal Investigator
University of Miami

Camillo Ricordi
NCT Number
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Calcium heparin