Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells … (NCT05387278) | Clinical Trial Compass
SuspendedPhase 1
Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)
Stopped: Sponsor request
United States20 participantsStarted 2025-03-20
Plain-language summary
Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. The biggest medical challenge in the response to COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator dependence. Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients.
The purpose of this study is to explore the safety and benefits of intravenous administration of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. .
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female, aged at 18 years (including) to 75 years old.
✓. Patient with a confirmed SARS-CoV-2 infection (by positive reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal sample or any other sample)
✓. Hospitalized with moderate to severe ARDS.
✓. Have ARDS or acute lung injury, comply with any of the following:
✓. If childbearing age: agree to practice effective birth control from screening until 12 weeks after the last study treatment.
Exclusion criteria
✕. Patient under invasive mechanical ventilation for more than 48 hours
✕. Allergic or hypersensitive to any of the ingredients.
✕. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses.
✕. Obstructive HABP/VABP induced by lung cancer or other known causes.
What they're measuring
1
To Assess the safety of EV-Pureâ„¢ and WJ-Pureâ„¢ administration in patients exhibiting moderate to severe ARDS associated with COVID-19, compared to placebo.
Timeframe: 3 months
2
To assess the efficacy of EV-Pureâ„¢ and WJ-Pureâ„¢ compared to placebo, in patients with moderate to severe ARDS assoociated with COVID-19