- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355728
Use of UC-MSCs for COVID-19 Patients
Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Diabetes Research Institute, University of Miami Miller School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.
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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.
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Best supportive care treatment per the treating hospital protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Pre-Specified Infusion Associated Adverse Events
Time Frame: 6 and 24 hours
|
Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion:
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6 and 24 hours
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Number of Subjects With Serious Adverse Events by 31 Days After First Infusion
Time Frame: 31 days
|
The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion).
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31 days
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Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90
Time Frame: 90 days
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Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician.
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90 days
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Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 90 days
|
Total number of adverse events and serious adverse events as assessed by treating physician
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90 days
|
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
Time Frame: 90 days
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Total number of adverse events plus serious adverse events categorized by severity.
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90 days
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Subjects With Adverse Events and Serious Adverse Events by Severity
Time Frame: 90 days
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Total number of subjects with adverse events and serious adverse events categorized by severity.
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90 days
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Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment
Time Frame: 90 days
|
Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional.
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90 days
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Subjects With Adverse Events by Relatedness to Treatment
Time Frame: 90 days
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Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional
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90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival at 31 Days Post First Infusion
Time Frame: 31 Days
|
Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion.
|
31 Days
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Survival at 60 Days Post First Infusion
Time Frame: 60 days
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Number of participants alive at 60 days post first infusion follow up.
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60 days
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Time to Recovery
Time Frame: 31 days
|
Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days.
The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered.
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31 days
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Ventilator-Free Days Throughout 28 Days Post Second Infusion
Time Frame: 28 days post second infusion
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Number of days participants were off ventilators during 28 days post second infusion.
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28 days post second infusion
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Ventilator-Free Days Throughout 90 Days
Time Frame: 90 days or hospital discharge, whichever is earlier
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Number of days participants were off ventilators within up to 90 days of hospitalization.
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90 days or hospital discharge, whichever is earlier
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Respiratory Rate and Oxygenation Index (ROX Index)
Time Frame: day 6
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Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate.
This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia.
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day 6
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Oxygenation Index (OI)
Time Frame: day 6
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Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy).
The calculation for Oxygenation index is ((FIO2 * Mean airway pressure)/partial pressure of oxygen).
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day 6
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Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat)
Time Frame: day 6
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Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6)
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day 6
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Sequential Organ Failure Assessment (SOFA) Scores
Time Frame: Day 6
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Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU).
The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems.
Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure).
The total score corresponds to the sum of the six different scores of the organ systems.
In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure).
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Day 6
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Smell Identification Test (SIT) Scores
Time Frame: 90 days
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SIT measures the participant's sense of smell.
SIT has a total score ranging from 0 to 40 with the higher the score indicating a more normal sense of smell
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90 days
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White Blood Cell Count (WBC)
Time Frame: day 6
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As assessed via serum blood samples.
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day 6
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Platelets Count
Time Frame: day 6
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As assessed via serum blood samples.
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day 6
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Hemogoblin
Time Frame: day 6
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Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples.
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day 6
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Hematocrit
Time Frame: day 6
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The percentage by volume of red cells in your blood as assessed via serum blood samples.
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day 6
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Neutrophils
Time Frame: day 6
|
the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples
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day 6
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Lymphocytes
Time Frame: day 6
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Lymphocyte count as assessed via serum blood samples
|
day 6
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Glomerular Filtration Rate
Time Frame: day 6
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Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working.
It estimates how much blood passes through the glomeruli each minute.
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day 6
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Total Protein
Time Frame: Day 6
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Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP).
It is a measurement of the sum of albumin and globulins.
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Day 6
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Sodium
Time Frame: day 6
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Sodium levels as assessed by serum blood samples.
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day 6
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Potassium
Time Frame: day 6
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Potassium levels as assessed via serum blood samples.
|
day 6
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Creatinine
Time Frame: day 6
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Creatinine levels as assessed via serum blood samples
|
day 6
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Glucose
Time Frame: day 6
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Glucose levels as assessed via serum blood samples
|
day 6
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Albumin
Time Frame: day 6
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Albumin levels as assessed via serum blood samples
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day 6
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Alkaline Phosphatase
Time Frame: day 6
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Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel.
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day 6
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Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)
Time Frame: day 6
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The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples
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day 6
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Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)
Time Frame: day 6
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The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples
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day 6
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Total Bilirubin
Time Frame: day 6
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Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel.
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day 6
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Blood Urea Nitrogen (BUN)
Time Frame: day 6
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Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel.
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day 6
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Calcium
Time Frame: day 6
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Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel.
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day 6
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Chloride
Time Frame: day 6
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Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel.
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day 6
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Carbon Dioxide (CO2)
Time Frame: day 6
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Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel.
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day 6
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C-Reactive Protein Levels
Time Frame: day 6
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As assessed via serum blood samples.
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day 6
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Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio
Time Frame: day 6
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As assessed via serum blood samples on day 6 (visit 8).
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day 6
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D-dimer Levels
Time Frame: day 6
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As assessed via serum blood samples.
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day 6
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25-Hydroxy Vitamin D Levels
Time Frame: day 6
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As assessed via serum blood samples.
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day 6
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Tumor Necrosis Factor-alpha (TNFα)
Time Frame: day 6
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Analysis of TNFα in peripheral blood plasma
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day 6
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Tumor Necrosis Factor-beta (TNFβ)
Time Frame: day 6
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Analysis of TNFβ in peripheral blood plasma
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day 6
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Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)
Time Frame: day 6
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Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma
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day 6
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Viral Load by SARS-CoV-2 RT-PCR
Time Frame: day 6
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Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
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day 6
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Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion
Time Frame: day 3 post first infusion
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Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples.
These antibodies can develop following a transplant.
Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
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day 3 post first infusion
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Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion
Time Frame: day 6
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Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples.
These antibodies can develop following a transplant.
Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
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day 6
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Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion
Time Frame: day 14
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Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples.
These antibodies can develop following a transplant.
Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
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day 14
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Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG
Time Frame: day 14 post first infusion
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Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples.
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day 14 post first infusion
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Coronavirus Infections
- Syndrome
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin
- Calcium heparin
Other Study ID Numbers
- 20200671
- 20200370 (OTHER: Secondary Protocol ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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