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

NCT ID: NCT04345601

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-12
• Study Completion Date: 2023-01-10

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safety Run In

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.

Group Type: EXPERIMENTAL

Mesenchymal Stromal Cells

Intervention Type: BIOLOGICAL

Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.

Mesenchymal stromal cells

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.

Group Type: EXPERIMENTAL

Mesenchymal Stromal Cells

Intervention Type: BIOLOGICAL

Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10\^8 MSCs.

Control Group

Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians.

Group Type: OTHER

Supportive Care

Intervention Type: OTHER

Patients will receive supportive care per their treating physician

Interventions

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.

Intervention Type: BIOLOGICAL

Supportive Care

Patients will receive supportive care per their treating physician

Intervention Type: OTHER

Other Intervention Names

MSCs

Eligibility 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 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):

1. Moderate ARDS: PaO2/FiO2 100-200 mmHg OR

2. Severe ARDS: PaO2/FiO2 ≤100 mmHg

4. If on invasive or noninvasive (BiPAP) mechanical ventilator, PEEP ≥5 cm H2O

5. Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.

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 as deemed by the treating physician/investigator including but not limited to unstable, ventricular tachycardia or new cardiac arrythmia requiring cardioversion.

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.

10. Respiratory failure not fully explained by cardiac failure or fluid overload.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

Sponsor Role: collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

LaQuisa Hill

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LaQuisa Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Houston Methodist Hospital

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

H-47561 MSC for COVID-19

Identifier Type: -

Identifier Source: org_study_id