COVID-19 InfectionPhase 1/2NCT04565665

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

A Phase 1/2 study testing Best Practice and Mesenchymal Stem Cell in people with COVID-19 Infection and COVID-19-Associated Acute Respiratory Distress Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome, Hematopoietic and Lymphoid Cell Neoplasm
What is being tested?: Best Practice and Mesenchymal Stem Cell
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: 29 Jul 2020to 30 Oct 2027
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVE:

To assess the safety of administering cord blood derived mesenchymal stem cell (CB-MSC) infusions for treatment of moderate, severe or critical pneumonia.

SECONDARY OBJECTIVES:

In the group of participants who present intubated on ventilator support, assess the proportion that are able to be successfully extubated.
In the group of participants who present requiring supplemental oxygen but otherwise breathing without assistance, assess the rate of progression to intubation.
Estimate the survival rate at day 30 post treatment separately by group.
Determine the treatment effect on clinical parameters, oxygenation and respiratory parameters:

Resolution of fever
Changes in oxygen demand (increased oxygen saturation at similar FiO2 or decreased FiO2 requirement)
Progression to mechanical ventilation
Length of Mechanical ventilation
Decrease in PEEP in intubated participants
Decrease in FiO2 in intubated participants

Determine the treatment effect on laboratory markers:

Complete blood count
CRP
Ferritin
D Dimer
Procalcitonin
Cytokine levels

Estimate hospitalization and ICU stay.
Report on study related adverse events.

OUTLINE:

Currently not shipping cells outside of MD Anderson Cancer Center in Houston.

PILOT STUDY: Patients receive MSCs intravenously (IV) over 1-2 hours on day 1. participants may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.

PHASE II STUDY: Patients are randomized to 1 of 2 arms.

ARM I: Patients 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.

ARM II: Patients receive standard of care.

After completion of study treatment, patients are followed up at days 7, 14, 30, 60, and months 6 and 12.

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
Being tested: Best Practice, Mesenchymal Stem Cell
Medical subject headings: COVID-19, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Mesenchymal Stem CellBiological
Also called Mesenchymal Progenitor Cell, MPC
Given IV

Study groups in NCT04565665
Study group	Role	What they receive
Phase II Arm I (mesenchymal stem cells)	Experimental	Patients receive MSCs as in the Pilot study. Receives: Biological: Mesenchymal Stem Cell
Phase II Arm II (standard of care)	Active comparator	Patients receive standard of care. Receives: Other: Best Practice
Pilot study (mesenchymal stem cells)	Experimental	Patients 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. Receives: Biological: Mesenchymal Stem Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 30 days of the first mesenchymal stem cell (MSC) infusion
Patients alive without grade 3, 4 infusional toxicity (Phase II)
Measured: At day 30 post MSC infusion
Patients alive with grade 3 or 4 infusional toxicity (Phase II)
Measured: At day 30 post MSC infusion
Patients not alive (Phase II)
Measured: At day 30 post MSC infusion

Secondary outcomes (12)

Proportion of successfully extubated patients who present intubated on ventilator support (Phase I)
Will be estimated and reported with 95% confidence intervals.
Measured: 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)
Will be estimated and reported with 95% confidence intervals.
Measured: Up to day 30 post MSC infusion
Overall survival rate (Phase I)
Will be estimated and reported with 95% confidence intervals.
Measured: At day 30 post MSC infusion
Survival rate in patients who present intubated on ventilator support (Phase I)
Will be estimated and reported with 95% confidence intervals.
Measured: 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)
Will be estimated and reported with 95% confidence intervals.
Measured: At day 30 post MSC infusion
Clinical parameters (Phase I)
The effect of MSCs on clinical parameters will be assessed. Continuous clinical parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables.
Measured: Up to day 30 post MSC infusion
Oxygenation parameters (Phase I)
The effect of MSCs on oxygenation parameters will be assessed. Continuous oxygenation parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables.
Measured: Up to day 30 post MSC infusion
Respiratory parameters (Phase I)
The effect of MSCs on respiratory parameters will be assessed. Continuous respiratory parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables.
Measured: Up to day 30 post MSC infusion
Laboratory markers (Phase I)
The effect of MSCs on laboratory markers will be assessed. Continuous laboratory parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables.
Measured: Up to day 30 post MSC infusion
Hospitalization stay (Phase I)
Measured: Up to day 30 post MSC infusion
Intensive care unit stay (Phase I)
Measured: Up to day 30 post MSC infusion
Incidence of infusion-related adverse events (Phase I)
All grades of infusion-related adverse events will be summarized by grade and type.
Measured: Up to day 30 post MSC infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 202030 Oct 2027

First posted25 Sep 2020
Study start29 Jul 2020
Primary completion30 Oct 2027 (estimated)
Study completion30 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 65 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04565665
Sponsor's protocol ID: 2020-0365
Other IDs: NCI-2020-06741, 2020-0365
Status last verified: Oct 2026
First submitted: 22 Sep 2020
Last updated: 5 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
ClinicalTrials.gov ID: NCT04565665
Acronym / sponsor ID: 2020-0365
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
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 65 participants (estimated)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 29 Jul 2020 (actual)
Primary completion: 30 Oct 2027 (estimated)
Study completion: 30 Oct 2027 (estimated)
First posted: 25 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

To assess the safety of administering cord blood derived mesenchymal stem cell (CB-MSC) infusions for treatment of moderate, severe or critical pneumonia.

SECONDARY OBJECTIVES:

In the group of participants who present intubated on ventilator support, assess the proportion that are able to be successfully extubated.
In the group of participants who present requiring supplemental oxygen but otherwise breathing without assistance, assess the rate of progression to intubation.
Estimate the survival rate at day 30 post treatment separately by group.
Determine the treatment effect on clinical parameters, oxygenation and respiratory parameters:

Resolution of fever
Changes in oxygen demand (increased oxygen saturation at similar FiO2 or decreased FiO2 requirement)
Progression to mechanical ventilation
Length of Mechanical ventilation
Decrease in PEEP in intubated participants
Decrease in FiO2 in intubated participants

Determine the treatment effect on laboratory markers:

Complete blood count
CRP
Ferritin
D Dimer
Procalcitonin
Cytokine levels

Estimate hospitalization and ICU stay.
Report on study related adverse events.

OUTLINE:

Currently not shipping cells outside of MD Anderson Cancer Center in Houston.

PILOT STUDY: Patients receive MSCs intravenously (IV) over 1-2 hours on day 1. participants may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.

PHASE II STUDY: Patients are randomized to 1 of 2 arms.

ARM I: Patients 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.

ARM II: Patients receive standard of care.

After completion of study treatment, patients are followed up at days 7, 14, 30, 60, and months 6 and 12.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase II Arm I (mesenchymal stem cells)	Experimental	Biological: Mesenchymal Stem CellPatients receive MSCs as in the Pilot study.
Phase II Arm II (standard of care)	Active comparator	Other: Best PracticePatients receive standard of care.
Pilot study (mesenchymal stem cells)	Experimental	Biological: Mesenchymal Stem CellPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Best PracticeAlso: standard of care, standard therapyReceive standard of care	Other	Phase II Arm II (standard of care)
Mesenchymal Stem CellAlso: Mesenchymal Progenitor Cell, MPCGiven IV	Biological	Phase II Arm I (mesenchymal stem cells), Pilot study (mesenchymal stem cells)

Primary outcome

Incidence of composite serious adverse events (Phase I)
Time frame: Within 30 days of the first mesenchymal stem cell (MSC) infusion
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.
Patients alive without grade 3, 4 infusional toxicity (Phase II)
Time frame: At day 30 post MSC infusion
Patients alive with grade 3 or 4 infusional toxicity (Phase II)
Time frame: At day 30 post MSC infusion
Patients not alive (Phase II)
Time frame: At day 30 post MSC infusion

12 secondary outcomes

Proportion of successfully extubated patients who present intubated on ventilator support (Phase I)
Time frame: 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)
Time frame: Up to day 30 post MSC infusion
Overall survival rate (Phase I)
Time frame: At day 30 post MSC infusion
Survival rate in patients who present intubated on ventilator support (Phase I)
Time frame: 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)
Time frame: At day 30 post MSC infusion
Clinical parameters (Phase I)
Time frame: Up to day 30 post MSC infusion
Oxygenation parameters (Phase I)
Time frame: Up to day 30 post MSC infusion
Respiratory parameters (Phase I)
Time frame: Up to day 30 post MSC infusion
Laboratory markers (Phase I)
Time frame: Up to day 30 post MSC infusion
Hospitalization stay (Phase I)
Time frame: Up to day 30 post MSC infusion
Intensive care unit stay (Phase I)
Time frame: Up to day 30 post MSC infusion
Incidence of infusion-related adverse events (Phase I)
Time frame: Up to day 30 post MSC infusion

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
M D Anderson Cancer CenterLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amanda Olson principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of composite serious adverse events (Phase I) (time frame: Within 30 days of the first mesenchymal stem cell (MSC) infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04565665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.