Acute Respiratory Distress SyndromePhase 1NCT04524962
Study of Descartes-30 in Acute Respiratory Distress Syndrome
A Phase 1 study testing Descartes 30 in people with Acute Respiratory Distress Syndrome and Covid19, run by Cartesian Therapeutics at 2 sites in United States.
Trial summary
Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Covid19
- What is being tested?
- Descartes 30
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Feb 2021to 9 Sep 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older at the time of enrollment
- Patient maintains a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS
Who cannot join
- Patient is currently enrolled into another therapeutic clinical trial with an experimental therapy that has not received marketing approval by U.S. FDA.
- Patient is in moribund state with expected survival <24 hours.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center Medical Center
Baltimore, Maryland, 21201
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Phase I/IIA Study of Descartes-30 in Acute Respiratory Distress Syndrome
Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19
- Conditions
- Acute Respiratory Distress Syndrome, Covid19
- Being tested
- Descartes 30
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descartes 30Biological
Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases.
| Study group | Role | What they receive |
|---|---|---|
| Descartes 30 | Experimental | Not described Receives: Biological: Descartes 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.
Safety will be determined principally by assessment of adverse events (AEs) and serious adverse events (SAEs).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start23 Feb 2021
- Primary completion9 Sep 2022
- Study completion9 Sep 2023
Why it stopped: Phase 1 enrollment completed. Further clinical development terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartesian Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524962
- Sponsor's protocol ID
- DC30-1A
- Other IDs
- 5R44HL158446, 2021-MSCRFCL-5
- Status last verified
- Oct 2024
- First submitted
- 19 Aug 2020
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIA Study of Descartes-30 in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04524962
- Acronym / sponsor ID
- DC30-1A
- Conditions
- Acute Respiratory Distress Syndrome, Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase 1 enrollment completed. Further clinical development terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cartesian TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2023 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Descartes 30 | Experimental | Biological: Descartes 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be 18 years of age or older at the time of enrollment
- Patient maintains a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS
Key exclusion criteria (2 listed)
- Patient is currently enrolled into another therapeutic clinical trial with an experimental therapy that has not received marketing approval by U.S. FDA.
- Patient is in moribund state with expected survival <24 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 |
|---|---|---|
| Descartes 30Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases. | Biological | Descartes 30 |
Primary outcome
To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.
Time frame: 3 months
Safety will be determined principally by assessment of adverse events (AEs) and serious adverse events (SAEs).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Descartes 30 in people with Acute Respiratory Distress Syndrome and Covid19, run by Cartesian Therapeutics at 2 sites in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS. (time frame: 3 months). 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 29 Oct 2024.