Using cord blood stem cells to treat pneumonia caused by COVID-19

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

This study is testing whether using stem cells from cord blood can help people with moderate to severe pneumonia caused by COVID-19 breathe better and recover more effectively than standard treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT04565665 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of cord blood-derived mesenchymal stem cells (CB-MSCs) for treating patients with moderate to critical pneumonia related to COVID-19. The study consists of a phase I trial to assess feasibility and safety, followed by a phase II randomized trial comparing the effects of MSC infusions to standard care. Participants will receive MSC infusions intravenously, and various clinical and laboratory parameters will be monitored to evaluate treatment outcomes. The trial aims to determine if MSCs can improve respiratory function and overall survival in affected patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with moderate to critical COVID-19-associated pneumonia requiring respiratory support.

Not a fit: Patients with mild pneumonia or those not infected with COVID-19 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from severe pneumonia due to COVID-19.

How similar studies have performed: While the use of MSCs for treating respiratory conditions is being explored, this specific approach for COVID-19 pneumonia is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Age greater than or equal 18 years.
2. Participants with 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 with oxygen saturation less than 93% on room air\*\*
3. Participants with COVID-19 associated pneumonia must meet baseline categorization of Moderate, Severe or Critical COVID-19 per FDA Guidance for Industry COVID-19: Developing Drugs and Biologics Products for Treatment or Prevention, February 2021.
4. Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
5. Participant or legally authorized representative consent. Participants with diminished mental capacity may be allowed on to enroll on the study.
6. Because of the nature of COVID-19, participants enrolled on this study with COVID-19 associated pneumonia may have been previously enrolled in other IND trials for their cancer diagnosis or for COVID-19. These enrollments will not exclude them from enrollment to this study.

Exclusion Criteria:

* 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

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Amanda Olson — M.D. Anderson Cancer Center
• Study coordinator: Bethany Overman

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