Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure

DSC-COVID-19: An Open-label Study on the Safety and Efficacy of Decidual Stromal Cells in Respiratory Failure Induced by COVID-19

This is a research study to see how safe and effective decidual stromal cells are in treating patients with respiratory failure (breathing problem where not enough oxygen is passed from the lungs into the blood) caused by COVID-19.

Study Overview

• Status: Completed
• Conditions: COVID-19; Acute Respiratory Distress Syndrome
• Intervention / Treatment: Biological: Decidual Stromal Cells (DSC)

Detailed Description

COVID-19 viral infectious disease that has lead to high numbers of critically ill patients or death due to respiratory failure.

Decidual Stromal Cells (DSC) may be useful in the treatment of acute respiratory distress syndrome (ARDS) by reducing lung inflammation and then time that patients require help with breathing (mechanical ventilation).

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • Brampton Civic Hospital
    • Etobicoke, Ontario, Canada, M9V 1R8
      • Etobicoke General Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to provide informed consent for participation in the study, either by the participant themselves or by the legally acceptable representative (LAR)
• Virological diagnosis of SARS-CoV-2 infection (PCR)
• Acute respiratory distress syndrome (ARDS) not due to cardiac causes
• Receiving mechanical ventilation

Exclusion Criteria:

• Severe comorbidity with life expectancy <3 months according to investigators assessment
• Currently receiving extracorporeal membrane oxygenation (ECMO)
• Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia
• Patients with diagnosed significant pulmonary embolism or deep vein thrombosis in the previous 3 months
• Patients who have been intubated for more than 48 hours
• Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins
• Acute co-morbidity within 7 days before inclusion such as stroke
• History of severe chronic history of heart disease, recent myocardial infarction or unstable angina, lung disease (requiring home oxygen), pulmonary hypertension, or liver comorbidities
• Malignancy that requires treatment in the previous two years (excluding non-melanoma skin malignancies treated by excision, or cryotherapy)
• History of immunosuppression (immunomodulators or anti-rejection drugs in past year, or active disease, autoimmune disease on treatment, transplant recipients) or anaphylaxis
• Refusal of blood products
• Severe co-morbidity/co-morbidities which in the opinion of the investigators would compromise safety assessments
• Pregnant or breast-feeding
• Actively participating on another trial of an investigational agent for ARDS
• Unacceptable laboratory blood tests for alanine aminotransferase (ALT)/aspartate aminotransferase (AST), neutrophils, or platelets

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decidual Stromal Cells (DSC); Participants will receive one dose of DSC at 1x10^6/kg. A second dose may be given sometime between Day 5 and Day 8 if the participant's condition improves.	Biological: Decidual Stromal Cells (DSC); DSCs are involved in the immune system during pregnancy. The DSCs used in this study will come from laboratory grown allogeneic human decidual stromal cells obtained from donated placentas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of ventilator free days following infusion of decidual stromal cells	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality rate from COVID-19	28 days
Mortality rate from COVID-19	60 days
Mortality rate from COVID-19	180 days
All-cause morality rate	28 days
All-cause morality rate	60 days
All-cause morality rate	180 days
Average number of days in ICU	180 days
Average number of days of hospital admittance	180 days
Average days not requiring vasopressors	180 days
Overall survival rate	180 days
Average viral clearance	180 days
Average number of days of supplemental oxygenation	180 days
Average number of day without supplemental oxygen	180 days
Mean PaO2/FiO2 as compared to patient baseline	180 days

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Oslo University Hospital
• Investigators: Principal Investigator: John Granton, M.D., Toronto General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Actual): November 7, 2023
• Study Completion (Actual): November 7, 2023

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: U-DEPLOY: DSC-COVID-19; 20-5527 (Other Identifier: University Health Network)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No