Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2020-04-25
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
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.
Vehicle + Heparin along with best supportive care
Best supportive care treatment per the treating hospital protocol.
Interventions
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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.
Vehicle + Heparin along with best supportive care
Best supportive care treatment per the treating hospital protocol.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Camillo Ricordi
OTHER
Responsible Party
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Camillo Ricordi
Professor of Surgery and Chief, Division of Cellular Transplantation
Principal Investigators
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Camillo Ricordi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20200370
Identifier Type: OTHER
Identifier Source: secondary_id
20200671
Identifier Type: -
Identifier Source: org_study_id