Phase I, Randomized, Double Blinded, Placebo Control Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 With Moderate to Severe Symptoms

Joshua M Hare0 sitesOctober 1, 2022

ConditionsCOVID-19 Acute Respiratory Distress Syndrome Corona Virus Infection

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19
Sponsor: Joshua M Hare
Primary Endpoint: Percent of participants with treatment related Serious Adverse Events (SAE)
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

June 1, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Joshua M Hare

Responsible Party

Sponsor Investigator

Principal Investigator

Joshua M Hare

Director of ISCI, Louis Lemberg Professor of Medicine

University of Miami

Eligibility Criteria

Inclusion Criteria

•Provide written informed consent
•Male or female subjects age \> 18 years at the time of signing the Informed Consent Form.
•COVID-19 positive according to diagnosis (evaluated by reverse transcription (RT)-polymerase chain reaction (PCR) test confirming infection with severe acute respiratory syndrome coronavirus and clinical management of COVID-19 criteria (refer to appendix B)
•Individuals with moderate to severe COVID-19 symptoms.
•Moderate:
•Patients with moderate disease are symptomatic (e.g. fever, cough, headache, myalgia, sore throat, nasal congestion, nausea, vomiting, diarrhea, fatigue, anosmia, or dysgeusia) and have abnormal chest imaging or some degree of hypoxia requiring supplemental oxygen but not intubation.
•Moderate-severe:
•The Moderately Severe disease category includes patients who are symptomatic (as described above), have abnormal chest imaging, but also have worsening hypoxia compatible with mild acute respiratory distress syndrome (ARDS) (Partial Pressure of Oxygen (PaO2)/Fraction of Inspired Oxygen (FiO2) \</= 300 but \> 200) - Berlin criteria; but do not yet require intubation .
•Adequate venous access
•For female patients only, willingness to use FDA-recommended birth control until 6 months post treatment.

Exclusion Criteria

•PaO2/FiO2 \</= 200
•Anticipated intubation within 24h
•Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening and prior to infusion.
•Inability to perform any of the assessments required for endpoint analysis.
•Subjects that are unsuitable with the study requirements .
•Active listing (or expected future listing) for transplant of any organ.
•Have known allergies to penicillin or streptomycin.
•Be a solid organ transplant recipient. This does not include prior cell-based therapy (\>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
•Have a history of organ or cell transplant rejection
•Has a history of an adverse response to cell-based therapy

Outcomes

Primary Outcomes

Percent of participants with treatment related Serious Adverse Events (SAE)

Time Frame: 12 months

Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.

Secondary Outcomes

Rate of Mortality(Up to 30 Days)
Change in systemic inflammatory marker levels(Baseline, Day 30)
COVID-19 Viral Load(Up to 30 Days)
Change in SOFA score(Baseline, Up to 30 Days)
Change in LDH levels(Baseline, Up to 30 Days)
Change in inflammatory marker levels(Baseline, Day 30)
Change in electrolytes levels(Baseline, Up to 30 Days)
Percentage of participants with changes in immune marker expression(Up to 30 Days)
Number of subjects discharged from the ICU(Up to 7 Days)
Percentage of participants with less requirement for vasoactive agents(Up to 30 Days)
Percentage of participants with changes in radiologic findings(Up to 30 Days)
Percentage of participants with less pneumonia symptoms(Up to 30 Days)