RecruitingPhase 1Phase 2NCT04565665

Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia

Sponsor

M.D. Anderson Cancer Center

Enrollment

70 participants

Start Date

Jul 29, 2020

Study Type

INTERVENTIONAL

Conditions

Malignant Solid Neoplasm Hematopoietic and Lymphoid Cell Neoplasm COVID-19 Infection COVID-19-Associated Acute Respiratory Distress Syndrome Symptomatic COVID-19 Infection Laboratory-Confirmed

Summary

This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether stem cells derived from umbilical cord blood can help treat moderate to severe pneumonia in adults, including pneumonia caused by COVID-19. Stem cells may help reduce dangerous lung inflammation. **You may be eligible if...** - You are 18 or older - You have pneumonia confirmed by chest X-ray with signs of at least moderate illness (such as a fast breathing rate or oxygen levels below 93% on room air) - If you have COVID-19 pneumonia, it must be classified as moderate, severe, or critical - You are not pregnant (negative pregnancy test required) - You or your legal representative can provide consent **You may NOT be eligible if...** - Your condition is so severe that survival beyond 48 hours is not expected - You have severe chronic liver disease - You are pregnant or breastfeeding - You are currently on a heart-lung bypass machine (ECMO) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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