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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451291
• Other study ID #: U-DEPLOY: DSC-COVID-19
• Secondary ID: 20-5527
• Status: Completed
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: November 7, 2023

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Canada	Brampton Civic Hospital	Brampton	Ontario
Canada	Etobicoke General Hospital	Etobicoke	Ontario
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Oslo University Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ventilator free days following infusion of decidual stromal cells		28 days
Secondary	Mortality rate from COVID-19		28 days
Secondary	Mortality rate from COVID-19		60 days
Secondary	Mortality rate from COVID-19		180 days
Secondary	All-cause morality rate		28 days
Secondary	All-cause morality rate		60 days
Secondary	All-cause morality rate		180 days
Secondary	Average number of days in ICU		180 days
Secondary	Average number of days of hospital admittance		180 days
Secondary	Average days not requiring vasopressors		180 days
Secondary	Overall survival rate		180 days
Secondary	Average viral clearance		180 days
Secondary	Average number of days of supplemental oxygenation		180 days
Secondary	Average number of day without supplemental oxygen		180 days
Secondary	Mean PaO2/FiO2 as compared to patient baseline		180 days