Use of UC-MSCs for COVID-19 Patients
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
- Corona Virus Infection
- ARDS
- ARDS, Human
- Acute Respiratory Distress Syndrome
- COVID-19
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
- 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
Arm | Description | Assigned 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. |
|
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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04355728
- Status
- Completed
- Sponsor
- Camillo Ricordi