Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias

NCT05286255 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 115966
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Keywords

Mesenchymal Stromal Cells; ARDS; COVID-19; MSC; Stem Cells

Outcome Measures

Primary Outcomes (1)

• Clinical deterioration

  Change in oxygen saturation or clinical symptoms

  6 hours

Secondary Outcomes (6)

• Serious Adverse Events

  90 days

• ICU transfer

  90 days

• Respiratory support

  90 days

• Hospital mortality and length of stay

  90 days

• Ventilator free days

  90 Days

Other Outcomes (3)

• Change is PaO2/FiO2 ratio from baseline to day 5

  5 days

• Anti-SARS-CoV-2 titers

  14, 21 and 28 days

• Nasopharyngeal swab SARS-CoV-2 RT-PCR

  Day 5

Study Arms (1)

Allogeneic Mesenchymal Stromal Cell infusion

EXPERIMENTAL

Intravenous infusion of 1.25-1.5 x 10\^6 cells/kg with a maximal dose of 100 x 10\^6 cells on days 1 and 3 after study enrollment.

Biological: Allogeneic Mesenchymal Stromal Cells

Interventions

Allogeneic Mesenchymal Stromal Cells BIOLOGICAL

Intravenous MSCs 1.2-1.5 x 10\^6 cells/kg on Days 1 and 3 after study enrollment

Allogeneic Mesenchymal Stromal Cell infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Pandorum International, Inc.: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pneumonia, Viral; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Charlie Strange, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single group, Phase 1 study

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 18, 2022
• Study Start: October 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Samples and Matching Participant data will be shared at the end of the study
• Access Criteria: Email to strangec@musc.edu

Locations

US (1)