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

Launched by M.D. ANDERSON CANCER CENTER · Sep 24, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of special cells called mesenchymal stem cells (MSCs) taken from umbilical cord blood to help treat patients suffering from pneumonia caused by COVID-19. The trial is divided into two parts: the first part (Phase I) is focused on seeing if it’s possible to safely treat patients with a serious condition called acute respiratory distress syndrome (ARDS) due to COVID-19. The second part (Phase II) will compare how well the MSC treatment works compared to standard care for these patients. MSCs are grown in a lab from healthy donors and may help relieve symptoms related to COVID-19 pneumonia.

To participate in this trial, you must be at least 18 years old and have pneumonia with specific symptoms that suggest moderate to severe illness, such as a fast breathing rate or low oxygen levels. Women who can become pregnant will need a negative pregnancy test. However, patients who are very ill and not expected to survive for at least 48 hours, or those with severe liver disease, cannot join the study. If you qualify and choose to participate, you will receive MSC infusions and be closely monitored throughout the study to see how well they help your condition. This trial is currently looking for participants, and your involvement could contribute to important research on potential treatments for COVID-19 related pneumonia.

Gender

ALL

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