NOT_YET_RECRUITING
Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias
This is an open-label phase 1 clinical trial of allogeneic umbilical cord derived mesenchymal stromal cells (MSCs) for hospitalized individuals with COVID-19 or other viral pneumonias. Hospitalized individuals who are within 7 days of the onset of a viral pneumonia will be given 2 doses of MSCs at days 1 and 3 after consent. The safety of intravenous infusion will be tested and course of the oxygen response to treatment over 90 days will be evaluated.
Conditions:
🦠 COVID-19 Pneumonia 🦠 Viral Pneumonia
🗓️ Study Start (Actual) September 2024
🗓️ Primary Completion (Estimated) December 2026
✅ Study Completion (Estimated) May 2027
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Charleston, South Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
    • 2. Patient or their surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
    • 3. Diagnosis with Mild or Moderate Pneumonia not requiring mechanical ventilation: Patient must have at least one of the following features:
    • i. Bilateral pneumonia present on chest radiograph or computed tomography ii. Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) on arterial blood gas showing: \>100mmHg and ≤ 300mmHg regardless of oxygen dose at time of testing.
    • iii. Pulse oxygen saturation (SpO2) at rest ≤ 93% or any degree of hypoxia requiring supplemental oxygen
    • 4. Patient agrees to storage of specimens for future testing.
    • 5. Willingness to undergo mechanical ventilation for worsening

    Exclusion Criteria:

    • 1. Intubation with mechanical ventilation prior to study enrolment. High flow nasal cannula and non-invasive mechanical ventilation is allowed.
    • 2. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses
    • 3. Obstructive pneumonia induced by lung cancer or other known causes
    • 4. Significant comorbid illness likely to impact the outcome of COVID-19 including but not limited to active malignancy other than skin cancer.
    • 5. Patients who are participating in other therapeutic clinical trials within 30 days of consent.
    • 6. History of long-term use of immunosuppressive agents including prednisone dose \>5mg daily over the 30 days prior to enrollment.
    • 7. History of severe chronic respiratory disease and requirement for long-term oxygen therapy
    • 8. Undergoing hemodialysis or peritoneal dialysis
    • 9. Estimated or actual rate of creatinine clearance \< 15 ml/min
    • 10. History of moderate and severe liver disease (Child-Pugh score \>12)
    • 11. Substance abuse sufficient that the patient is unlikely to comply with testing requirements.
    • 12. History of deep venous thrombosis, pulmonary embolism, cerebral vascular disease within the last 3 years
    • 13. Known HIV, hepatitis virus, or syphilis infection
    • 14. Co-Infection of tuberculosis, influenza virus, adenovirus and other respiratory infection virus
    • 15. Moribund patient not expected to survive \> 24hours
    • 16. Allergy to diphenhydramine, or hydrocortisone
    • 17. Any condition unsuitable for the study as determined by the investigators
    • 18. Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
    • 19. Receipt of experimental therapy for COVID-19 with the exception of convalescent plasma, dexamethasone or another corticosteroid, or remdesivir in an open label study.
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 March 2022
  • First Submitted that Met QC Criteria 16 March 2022
  • First Posted 18 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 November 2023
  • Last Update Posted 21 November 2023
  • Last Verified November 2023