RecruitingPhase 1/2

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

United States70 participantsStarted 2020-07-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age greater than or equal 18 years.
✓. 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\*\*
✓. 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.
✓. Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
✓. Participant or legally authorized representative consent. Participants with diminished mental capacity may be allowed on to enroll on the study.
✓. 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.

What they're measuring

Incidence of composite serious adverse events (Phase I)

Timeframe: Within 30 days of the first mesenchymal stem cell (MSC) infusion

Patients alive without grade 3, 4 infusional toxicity (Phase II)

Timeframe: At day 30 post MSC infusion

Patients alive with grade 3 or 4 infusional toxicity (Phase II)

Timeframe: At day 30 post MSC infusion

Patients not alive (Phase II)

Timeframe: At day 30 post MSC infusion

Trial details

NCT IDNCT04565665

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-30

Contact for this trial

Bethany Overman

713-745-4567 BJSpears@mdanderson.org

View on ClinicalTrials.gov More COVID-19 Infection trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age greater than or equal 18 years.
✓. 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\*\*
✓. 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.
✓. Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
✓. Participant or legally authorized representative consent. Participants with diminished mental capacity may be allowed on to enroll on the study.
✓. 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.

What they're measuring

Incidence of composite serious adverse events (Phase I)

Timeframe: Within 30 days of the first mesenchymal stem cell (MSC) infusion

Patients alive without grade 3, 4 infusional toxicity (Phase II)

Timeframe: At day 30 post MSC infusion

Patients alive with grade 3 or 4 infusional toxicity (Phase II)

Timeframe: At day 30 post MSC infusion

Patients not alive (Phase II)

Timeframe: At day 30 post MSC infusion