Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345601
Recruitment Status : Not yet recruiting
First Posted : April 14, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital System
Information provided by (Responsible Party):
LaQuisa Hill, Baylor College of Medicine

Brief Summary:

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).

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.


Condition or disease Intervention/treatment Phase
Sars-CoV2 Acute Respiratory Distress Syndrome COVID-19 Biological: Mesenchymal Stromal Cells Other: Supportive Care Early Phase 1

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:

  • 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.

These tests are done to assess the patient's eligibility to receive the cells. 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 a single intravenous (into the vein) infusion of 2 x 10^6 cells/kg of MSCs. The patient will be monitored closely for two hours after the infusion.

The patient will receive standard medical tests when getting the infusion 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Donor Banked Bone Marrow Mesenchymal Stromal Cells for the Treatment of COVID19-Induced ARDS: A Randomized, Controlled Study
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
Experimental: Mesenchymal stromal cells
Patients will receive up to 2 infusions of mesenchymal stem cells.
Biological: Mesenchymal Stromal Cells
Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs.
Other Name: MSCs

Control Group
Patients will receive supportive care or treatment designated by their treating doctor.
Other: Supportive Care
Patients will receive supportive care per their treating physician




Primary Outcome Measures :
  1. Treatment-related serious adverse events (tSAEs) [ Time Frame: 28 days post cell infusion ]
    Treatment-related serious adverse events (tSAE) will be considered as those directly related to the investigational infusion product per protocol defined criteria.

  2. Change in clinical status at day 14 [ Time Frame: 14 days post cell infusion ]
    Change by at least two categories on a six category ordinal scale at day 14 post randomization per protocol defined criteria. The six-category ordinal scale ranges from 6 to 1 with a higher score indicates worse clinical outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) 18 years or older 2) Confirmed SARS-CoV2 infection real-time reverse transcription polymerase chain reaction (RT-PCR) assay 3) Moderate to severe acute respiratory distress syndrome (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). Based on the Berlin criteria noted below.

  1. Moderate ARDS: PaO2/FiO2 100-200 mmHg, on invasive or noninvasive mechanical ventilation settings that include EEP ≥5 cm H2O
  2. Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O

AND

  • Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.
  • Respiratory failure not fully explained by cardiac failure or fluid overload.

Exclusion Criteria:

  1. Currently receiving extracorporeal membrane oxygenation (ECMO)
  2. Severe chronic respiratory disease requiring use of home oxygen
  3. Pregnant or lactating
  4. Known hypersensitivity to dimethyl sulfoxide (DMSO)
  5. Unstable hemodynamics (ventricular tachycardia or fibrillation)
  6. Uncontrolled bacterial or fungal co-infection
  7. Any end-stage organ disease or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment
  8. Inability to obtain informed consent (from patient or legally appropriate proxy)
  9. Presence of any contraindication to receiving prophylactic low dose unfractionated or low molecular weight heparin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345601


Contacts
Layout table for location contacts
Contact: LaQuisa Hill, MD (713) 441-1450 LaQuisa.Hill@bcm.edu

Locations
Layout table for location information
United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Contact: LaQuisa Hill, MD    713-441-1450    LaQuisa.Hill@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital System
Investigators
Layout table for investigator information
Principal Investigator: LaQuisa Hill, MD Baylor College of Medicine
Layout table for additonal information
Responsible Party: LaQuisa Hill, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04345601    
Other Study ID Numbers: H-47561 MSC for COVID-19
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by LaQuisa Hill, Baylor College of Medicine:
Mesenchymal Stromal Cells
Respiratory failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury