Purpose

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).

Conditions

Eligibility

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

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The trial has two groups, each with 12 subjects (n=24). All eligible subjects will be randomized to either the treatment group or standard of care, and randomization will be stratified by ARDS severity.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Double-Blinding Trial

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
UC-MSCs Group
Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.
  • 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.
Placebo Comparator
Control Group
Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.
  • Other: Vehicle + Heparin along with best supportive care
    Best supportive care treatment per the treating hospital protocol.

Recruiting Locations

More Details

NCT ID
NCT04355728
Status
Completed
Sponsor
Camillo Ricordi

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.