Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
2 other identifiers
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2020
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 29, 2020
CompletedFirst Submitted
Initial submission to the registry
September 22, 2020
CompletedFirst Posted
Study publicly available on registry
September 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
April 14, 2026
April 1, 2026
6.3 years
September 22, 2020
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Incidence of composite serious adverse events (Phase I)
Serious adverse events with be comprised of grade 3 or 4 graft versus host disease or death and will be estimated and reported overall and by group, along with 95% confidence intervals.
Within 30 days of the first mesenchymal stem cell (MSC) infusion
Patients alive without grade 3, 4 infusional toxicity (Phase II)
At day 30 post MSC infusion
Patients alive with grade 3 or 4 infusional toxicity (Phase II)
At day 30 post MSC infusion
Patients not alive (Phase II)
At day 30 post MSC infusion
Secondary Outcomes (12)
Proportion of successfully extubated patients who present intubated on ventilator support (Phase I)
Up to day 30 post MSC infusion
Rate of successful progression to intubation in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)
Up to day 30 post MSC infusion
Overall survival rate (Phase I)
At day 30 post MSC infusion
Survival rate in patients who present intubated on ventilator support (Phase I)
At day 30 post MSC infusion
Survival rate in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)
At day 30 post MSC infusion
- +7 more secondary outcomes
Study Arms (3)
Phase II Arm I (mesenchymal stem cells)
EXPERIMENTALPatients receive MSCs as in the Pilot study.
Phase II Arm II (standard of care)
ACTIVE COMPARATORPatients receive standard of care.
Pilot study (mesenchymal stem cells)
EXPERIMENTALPatients 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.
Interventions
Receive standard of care
Given IV
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda Olson
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2020
First Posted
September 25, 2020
Study Start
July 29, 2020
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
October 30, 2026
Last Updated
April 14, 2026
Record last verified: 2026-04