Cord Blood-Derived Mesenchymal Stem Cells for the Treatment of COVID-19 Related Acute Respiratory Distress Syndrome

Overseen by Amanda Olson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Amanda Olson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

Patients with moderate to severe ARDS per Berlin criteria secondary to COVID-19. Moderate to severe is defined in appendix as the following: moderate partial pressure of arterial oxygen (PaO2)/FiO2 of 100-200 mm Hg, severe PaO2/FiO2 of less than 100 mm Hg

Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization

Patient or legally authorized representative consent

Exclusion Criteria

Patients with severe chronic liver disease (Childs-Pugh score > 10)

You are currently receiving extracorporeal membrane oxygenation (ECMO) treatment.

You are pregnant or currently breastfeeding.

Treatment Details

Interventions

• Cord Blood-Derived Mesenchymal Stem Cells (Mesenchymal Stem Cell)

Participant Groups

Group I: Pilot study (mesenchymal stem cells) Experimental Treatment 1 Intervention

Patients receive MSCs IV over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.

Group II: Phase II Arm I (mesenchymal stem cells) Experimental Treatment 1 Intervention

Patients receive MSCs as in the Pilot study.

Group III: Phase II Arm II (standard of care) Active Control 1 Intervention

Patients receive standard of care.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School