COVID-19NCT04451291
Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure
A study testing Decidual Stromal Cells (DSC) in people with COVID-19 and Acute Respiratory Distress Syndrome, run by University Health Network, Toronto at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19, Acute Respiratory Distress Syndrome
- What is being tested?
- Decidual Stromal Cells (DSC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesCanada
- Study dates
- 25 Sep 2020to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Brampton Civic Hospital
Brampton, Ontario, L6R 3J7
Etobicoke General Hospital
Etobicoke, Ontario, M9V 1R8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
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
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.
Read the 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).
- Conditions
- COVID-19, Acute Respiratory Distress Syndrome
- Being tested
- Decidual Stromal Cells (DSC)
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decidual Stromal Cells (DSC)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Decidual Stromal Cells (DSC) | Experimental | 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. Receives: Biological: Decidual Stromal Cells (DSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator free days following infusion of decidual stromal cells
Measured: 28 days
Secondary outcomes (14)
Mortality rate from COVID-19
Measured: 28 days
Mortality rate from COVID-19
Measured: 60 days
Mortality rate from COVID-19
Measured: 180 days
All-cause morality rate
Measured: 28 days
All-cause morality rate
Measured: 60 days
All-cause morality rate
Measured: 180 days
Average number of days in ICU
Measured: 180 days
Average number of days of hospital admittance
Measured: 180 days
Average days not requiring vasopressors
Measured: 180 days
Overall survival rate
Measured: 180 days
Average viral clearance
Measured: 180 days
Average number of days of supplemental oxygenation
Measured: 180 days
Average number of day without supplemental oxygen
Measured: 180 days
Mean PaO2/FiO2 as compared to patient baseline
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start25 Sep 2020
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- John Granton, M.D., Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451291
- Sponsor's protocol ID
- U-DEPLOY: DSC-COVID-19
- Other IDs
- 20-5527
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2020
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04451291
- Acronym / sponsor ID
- U-DEPLOY: DSC-COVID-19
- Conditions
- COVID-19, Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decidual Stromal Cells (DSC) | Experimental | Biological: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Decidual Stromal Cells (DSC) |
Primary outcome
Number of ventilator free days following infusion of decidual stromal cells
Time frame: 28 days
14 secondary outcomes
Mortality rate from COVID-19
Time frame: 28 days
Mortality rate from COVID-19
Time frame: 60 days
Mortality rate from COVID-19
Time frame: 180 days
All-cause morality rate
Time frame: 28 days
All-cause morality rate
Time frame: 60 days
All-cause morality rate
Time frame: 180 days
Average number of days in ICU
Time frame: 180 days
Average number of days of hospital admittance
Time frame: 180 days
Average days not requiring vasopressors
Time frame: 180 days
Overall survival rate
Time frame: 180 days
Average viral clearance
Time frame: 180 days
Average number of days of supplemental oxygenation
Time frame: 180 days
Average number of day without supplemental oxygen
Time frame: 180 days
Mean PaO2/FiO2 as compared to patient baseline
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Granton, M.D. principal investigator
Toronto General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decidual Stromal Cells (DSC) in people with COVID-19 and Acute Respiratory Distress Syndrome, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ventilator free days following infusion of decidual stromal cells (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.