Status:
WITHDRAWN
Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Pandorum International, Inc.
Conditions:
COVID-19 Pneumonia
Viral Pneumonia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 in...
Detailed Description
Study Design: This open-label phase 1 trial in 10 patients will assess the efficacy and safety of UC-MSCs given on day 1 and 3 in hospitalized patients with acute respiratory symptoms between 1 and 7 ...
Eligibility Criteria
Inclusion
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
- Patient or their surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
- 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
- Patient agrees to storage of specimens for future testing.
- Willingness to undergo mechanical ventilation for worsening
Exclusion
- Intubation with mechanical ventilation prior to study enrolment. High flow nasal cannula and non-invasive mechanical ventilation is allowed.
- Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses
- Obstructive pneumonia induced by lung cancer or other known causes
- Significant comorbid illness likely to impact the outcome of COVID-19 including but not limited to active malignancy other than skin cancer.
- Patients who are participating in other therapeutic clinical trials within 30 days of consent.
- History of long-term use of immunosuppressive agents including prednisone dose \>5mg daily over the 30 days prior to enrollment.
- History of severe chronic respiratory disease and requirement for long-term oxygen therapy
- Undergoing hemodialysis or peritoneal dialysis
- Estimated or actual rate of creatinine clearance \< 15 ml/min
- History of moderate and severe liver disease (Child-Pugh score \>12)
- Substance abuse sufficient that the patient is unlikely to comply with testing requirements.
- History of deep venous thrombosis, pulmonary embolism, cerebral vascular disease within the last 3 years
- Known HIV, hepatitis virus, or syphilis infection
- Co-Infection of tuberculosis, influenza virus, adenovirus and other respiratory infection virus
- Moribund patient not expected to survive \> 24hours
- Allergy to diphenhydramine, or hydrocortisone
- Any condition unsuitable for the study as determined by the investigators
- Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- Receipt of experimental therapy for COVID-19 with the exception of convalescent plasma, dexamethasone or another corticosteroid, or remdesivir in an open label study.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05286255
Start Date
October 1 2024
End Date
October 1 2024
Last Update
October 30 2024
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425