Status:
COMPLETED
Use of UC-MSCs for COVID-19 Patients
Lead Sponsor:
Camillo Ricordi
Conditions:
Corona Virus Infection
ARDS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Complication...
Eligibility Criteria
Inclusion
- 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:
- Patient currently hospitalized
- Aged ≥ 18 years
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening
- PaO2/FiO2 ratio \< 300 mmHg
- Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
- 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
- PaO2/FiO2 ≥ 300 at the time of enrollment
- A previous MSC infusion not related to this trial
- History of Pulmonary Hypertension (WHO Class III/IV)
- History of left atrial hypertension or decompensated left heart failure.
- Pregnant or lactating patient
- Unstable arrhythmia
- Patients with previous lung transplant
- Patients currently receiving chronic dialysis
- Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
- Presence of any active malignancy (except non-melanoma skin cancer)
- Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
- Moderate to severe liver disease (AST and ALT \>5 X ULN)
- Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen
- Baseline QT prolongation
- Moribund patient not expected to survive \> 24 hours
Key Trial Info
Start Date :
April 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04355728
Start Date
April 25 2020
End Date
October 31 2020
Last Update
December 6 2021
Active Locations (1)
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1
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136