Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical … (NCT04565665) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
United States65 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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is Phase I/II and is actively measuring serious adverse events and infusional toxicities as primary outcomes, what does that tell us about how much is still unknown about the safety of this cord blood stem cell treatment?
2This trial is no longer recruiting new patients — does that mean there's any chance of joining, or should we focus entirely on other treatment options available to us right now?
3The trial includes both COVID-19 patients and people with certain cancers — given my specific situation, how would my doctor assess whether my condition fits the kind of patients this study was designed for?
4Since infusional toxicity — including serious Grade 3 and 4 reactions — is one of the key things being tracked, what would those reactions actually look like, and how would they be managed if they occurred?
5How does this experimental stem cell approach compare to standard treatments currently available for severe COVID-19 or COVID-19-related respiratory distress, and is there a reason to consider a trial like this over those established options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of composite serious adverse events (Phase I)
Timeframe: Within 30 days of the first mesenchymal stem cell (MSC) infusion
2
Patients alive without grade 3, 4 infusional toxicity (Phase II)
Timeframe: At day 30 post MSC infusion
3
Patients alive with grade 3 or 4 infusional toxicity (Phase II)
. 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.