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

NCT04345601 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-10-09

Study results available
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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.

Conditions

  • Sars-CoV2
  • Acute Respiratory Distress Syndrome
  • COVID-19

Interventions

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

Supportive Care

Patients will receive supportive care per their treating physician

Sponsors & Collaborators

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • LaQuisa Hill, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2023-01-10
Completion
2023-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345601 on ClinicalTrials.gov