Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04565665

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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-14

70

Participants Needed

1

Research Sites

326 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal 18 years.
  • Chest x-ray findings concerning for pneumonia from any cause, with clinical signs suggestive of at least moderate illness such as respiratory rate >20 breaths per minute or oxygen saturation less than 93% on room air.
  • COVID-19 associated pneumonia classified as moderate, severe or critical according to FDA guidance.
  • Negative pregnancy test in women with childbearing potential.
  • Participant or legally authorized representative consent.
  • Participants previously enrolled in other IND trials for cancer or COVID-19 are eligible.
Not Eligible

You will not qualify if you...

  • Moribund participants not expected to survive up to 48 hours.
  • Participants with severe chronic liver disease (Childs-Pugh score > 10).
  • Pregnant and/or lactating women.
  • Participants on extracorporeal membrane oxygenation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

B

Bethany Overman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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