Sars-CoV2Phase 1/2NCT04345601
Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)
A Phase 1/2 study testing Mesenchymal Stromal Cells and Supportive Care in people with Sars-CoV2 and Acute Respiratory Distress Syndrome, run by Baylor College of Medicine at 1 site in United States.
Trial summary
*At this time, we are only enrolling at Houston Methodist Hospital (HMH)/Baylor College of Medicine (BCM) and are not shipping cells outside of BCM/HMH.* This is a study for patients who have respiratory infection caused by SARS-CoV-2 that have not gotten better. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2, Acute Respiratory Distress Syndrome, COVID-19
- What is being tested?
- Mesenchymal Stromal Cells and Supportive Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2021to 10 Jan 2023
- Phase
- Phase 1/2
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
- 18 years or older
- Confirmed SARS-CoV2 infection real-time reverse transcription polymerase chain reaction (RT-PCR) assay
- Moderate OR severe ARDS, based on the degree of impairment of oxygenation as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2):
- Moderate ARDS: PaO2/FiO2 100-200 mmHg OR
- Severe ARDS: PaO2/FiO2 ≤100 mmHg
- If on invasive or noninvasive (BiPAP) mechanical ventilator, PEEP ≥5 cm H2O
- Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.
Who cannot join
- Currently receiving extracorporeal membrane oxygenation (ECMO)
- Severe chronic respiratory disease requiring use of home oxygen
- Pregnant or lactating
- Known hypersensitivity to dimethyl sulfoxide (DMSO)
- Unstable hemodynamics as deemed by the treating physician/investigator including but not limited to unstable, ventricular tachycardia or new cardiac arrythmia requiring cardioversion.
- Uncontrolled bacterial or fungal co-infection
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- Any end-stage organ disease or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment
- Inability to obtain informed consent (from patient or legally appropriate proxy)
- Presence of any contraindication to receiving prophylactic low dose unfractionated or low molecular weight heparin.
- Respiratory failure not fully explained by cardiac failure or fluid overload.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Donor Banked Bone Marrow Mesenchymal Stromal Cells for the Treatment of COVID-19 Induced ARDS: A Non-Blinded Randomized, Controlled Study
*At this time, we are only enrolling at Houston Methodist Hospital (HMH)/Baylor College of Medicine (BCM) and are not shipping cells outside of BCM/HMH.*
This is a study for patients who have respiratory infection caused by SARS-CoV-2 that have not gotten better. Because there is no standard treatment for this infection, patients are being asked to volunteer for a gene transfer research study using mesenchymal stem cells (MSCs).
Read more
Stem cells are cells that do not yet have a specific function in the body. Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown from bone marrow (the spongy tissue inside of bones). Stem cells can develop into other types of more mature (specific) cells, such as blood and muscle cells.
The purpose of this study is to see if MSCs versus controls can help to treat respiratory infections caused by SARS-CoV-2.
Read the detailed description
Earlier, a healthy donor provided blood cells to generate MSCs. These cells were grown and frozen for later use.
Before being treated, the patient will receive a series of standard medical tests: These tests are done to assess the patient's eligibility to receive the cells.
- Physical exam and history
- SARS-CoV-2 test
- Blood tests
- Chest X-ray or chest CT Scan
- A urine pregnancy test, when applicable
The patient will be randomly assigned to a study group. We'll use a computer to put the patient into study group A (study drug) or group B (control) by chance (randomized). Patients randomized to the control group, will receive the standard treatment for their respiratory infection.
On the day that the patient is scheduled to receive the cells they will be pre-medicated with Benadryl and Tylenol. The patient will then receive an intravenous (into the vein) infusion of 1 x 10^8 cells/kg of MSCs. The patient will be monitored closely for two hours after the infusion. The patient will receive a second infusion at the same dose within 3-5 days of the initial infusion (at the discretion of the investigator) if there is no improvement in respiratory parameters or if there is a worsening of Acute respiratory distress syndrome (ARDS).
The patient will receive standard medical tests when getting the infusion(s) and afterwards. As part of the research study, the patient will be evaluated daily for 7 days and then weekly at weeks 2, 3, and 4. The evaluations that will be done at these visits include:
- Physical exam and history
- SARS-CoV-2 test
- Blood tests
- Chest X-ray or chest CT Scan
- Conditions
- Sars-CoV2, Acute Respiratory Distress Syndrome, COVID-19
- Being tested
- Mesenchymal Stromal Cells, Supportive Care
- Keywords
- Mesenchymal Stromal Cells, Respiratory failure
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal CellsBiological
Also called MSCs
Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs.
Supportive CareOther
Patients will receive supportive care per their treating physician
| Study group | Role | What they receive |
|---|---|---|
| Safety Run In | Experimental | The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Receives: Biological: Mesenchymal Stromal Cells |
| Mesenchymal stromal cells | Experimental | Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Receives: Biological: Mesenchymal Stromal Cells |
| Control Group | Other | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Receives: Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs)
Treatment-related serious adverse events (tSAE) are those directly related to the investigational infusion product. Adverse event grading will be per NCI Common Terminology Criteria for Adverse Events(CTCAE), vs 5. Rate of tSAEs in patients treated with MSCs will be reported as proportion and its 95% confidence interval.
Measured: 28 days post cell infusion
Number of Participants With Improvement by at Least Two Categories on a Six Category Ordinal Scale at Day 14
Change by at least two categories on a six-category ordinal scale as improvement at day 14 post-randomization per protocol defined criteria. The six-category ordinal scale ranges from 6 to 1 with a higher score indicating a worse clinical outcome as follows: 6 ꞊ death; 5 ꞊ hospitalization, requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV); 4 ꞊ hospitalization, requiring non-invasive mechanical ventilation (NIV) and/or High-flow nasal cannula (HFNC) therapy; 3 = hospitalization, requiring supplemental oxygen (but not NIV/HFNC); 2 = hospitalization, not requiring supplemental oxygen; 1 = hospital discharge.
Measured: 14 days post cell infusion
Secondary outcomes (9)
Clinical Status Determined by 6-point Ordinal Scale at Day 28
Clinical status at day 28 as determined by 6-point ordinal scale as follows: 6 ꞊ death; 5 ꞊ hospitalization, requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV); 4 ꞊ hospitalization, requiring non-invasive mechanical ventilation (NIV) and/or High-flow nasal cannula (HFNC) therapy; 3 = hospitalization, requiring supplemental oxygen (but not NIV/HFNC); 2 = hospitalization, not requiring supplemental oxygen; 1 = hospital discharge. The six-category ordinal scale ranges from 6 to 1 with a higher score indicating a worse clinical outcome.
Measured: 28 days post cell infusion
Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14
ARDS is divided into 3 groups based on the degree of hypoxemia: mild (partial pressure of oxygen in the arterial blood(PaO2)/fraction of inspired oxygen(FIO2) 201-300 mm Hg), moderate (PaO2/FIO2: 101-200 mm Hg), and severe (PaO2/FIO2 ≤ 100 mm Hg) and ventilator settings with a positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm water (H2O).
Measured: 14 days post cell infusion
Number of Oxygenation Free Days at Day 28
Number of oxygen support-free days through Day 28
Measured: 28 days post cell infusion
Number of Participants With Progression to Mechanical Ventilation or ECMO
Participants not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation.
Measured: 28 days post cell infusion
Duration of Mechanical Ventilation and/or ECMO
Number of days requiring invasive mechanical ventilation and/or ECMO (ventilation/ECMO free days at day 28)
Measured: 28 days post cell infusion
Duration of ICU Stay
The number of days a participant spent in ICU. Duration of ICU stay is calculated from the date of admission or data of on study if the patient was admitted to ICU before enrollment to the time of ICU discharge, death, or last follow-up, whichever occurred first.
Measured: from the date of admission or data of on study if the patient was admitted to ICU before enrollment to the time of ICU discharge, death, or last follow-up, whichever occurred first. Up to 35 days.
Duration of Hospital Stay
Duration of hospital stay is calculated from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. It does not reflect the entire hospitalization time.
Measured: from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. Up to 35 days.
Overall Survival
Probability of overall survival is calculated using Kaplan-Meier survival curves per protocol. Overall survival time is defined as days from the date of randomization or date of infusion if received MSCs to the date of death or the date of the last follow-up for censoring.
Measured: 28 days post cell infusion
All-cause Mortality
Number and percentage of deaths (all-cause) until Day 28
Measured: 28 days post cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start12 Feb 2021
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- LaQuisa Hill, MD, Principal investigator, The Methodist Hospital Research InstituteHelen Heslop, MD, Study director, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345601
- Sponsor's protocol ID
- H-47561 MSC for COVID-19
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2020
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No