Back to results

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

Primary Purpose

COVID-19, Acute Respiratory Distress Syndrome

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Decidual Stromal Cells (DSC)

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brampton Civic Hospital
Etobicoke General Hospital
Toronto General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Decidual Stromal Cells (DSC)

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of ventilator free days following infusion of decidual stromal cells

Secondary Outcome Measures

Mortality rate from COVID-19

All-cause morality rate

Average number of days in ICU

Average number of days of hospital admittance

Average days not requiring vasopressors

Overall survival rate

Average viral clearance

Average number of days of supplemental oxygenation

Average number of day without supplemental oxygen

Mean PaO2/FiO2 as compared to patient baseline

Full Information

NCT ID

NCT04451291

First Posted

June 26, 2020

Last Updated

May 9, 2022

Sponsor

University Health Network, Toronto

Collaborators

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04451291

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 25, 2020 (Actual)

Primary Completion Date

September 25, 2022 (Anticipated)

Study Completion Date

March 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

Collaborators

Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Decidual Stromal Cells (DSC)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Decidual Stromal Cells (DSC)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of ventilator free days following infusion of decidual stromal cells

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Mortality rate from COVID-19

Time Frame

28 days

Title

Mortality rate from COVID-19

Time Frame

60 days

Title

Mortality rate from COVID-19

Time Frame

180 days

Title

All-cause morality rate

Time Frame

28 days

Title

All-cause morality rate

Time Frame

60 days

Title

All-cause morality rate

Time Frame

180 days

Title

Average number of days in ICU

Time Frame

180 days

Title

Average number of days of hospital admittance

Time Frame

180 days

Title

Average days not requiring vasopressors

Time Frame

180 days

Title

Overall survival rate

Time Frame

180 days

Title

Average viral clearance

Time Frame

180 days

Title

Average number of days of supplemental oxygenation

Time Frame

180 days

Title

Average number of day without supplemental oxygen

Time Frame

180 days

Title

Mean PaO2/FiO2 as compared to patient baseline

Time Frame

180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Granton, M.D.

Organizational Affiliation

Toronto General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brampton Civic Hospital

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6R 3J7

Country

Canada

Facility Name

Etobicoke General Hospital

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M9V 1R8

Country

Canada

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs