Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Respiratory Distress Syndrome
- COVID-19
- SARS COV2
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 tes...
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
Tracking Information
- NCT #
- NCT04345601
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine
- The Methodist Hospital System
- Investigators
- Principal Investigator: LaQuisa Hill, MD Baylor College of Medicine