Covid-19Phase 1NCT04522817
CLBS119 for Repair of COVID-19 Induced Pulmonary Damage
A Phase 1 study testing CLBS119 in people with Covid-19, run by Lisata Therapeutics, Inc. at 1 site in United States.
Trial summary
This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- CLBS119
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to May 2021
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Initial diagnosis with COVID-19 based on nasopharyngeal, oropharyngeal, or tracheobronchial aspirate SARS CoV-2 RT-PCR test
- Receiving or received ventilatory support for COVID-19 pneumonia/ARDS
- Evidence for ongoing pulmonary involvement based on P/F ratio <300
- Able to provide informed consent
Who cannot join
- Immunocompromised or current use of immunosuppressive agents other than corticosteroids
- History of autoimmune disease
- Evidence of multiorgan failure
- Subject is pregnant or lactating at the time of signing the consent
- Participation in any other clinical trial of an experimental treatment for COVID-19
- History of sickle cell disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage
This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.
Read the detailed description
This open-label clinical trial will explore the safety and potential efficacy of peripheral blood derived autologous CD34+ cells for the repair of COVID-19 induced pulmonary damage in adults. Eligible subjects will receive a single administration of CLBS119.
- Conditions
- Covid-19
- Being tested
- CLBS119
- Keywords
- Pneumonia, COVID, SARs-CoV-2, Pulmonary Inflammation, Respiratory Distress Syndrome, Lung Diseases, Lung Injury, Respiratory Tract Diseases, Respiratory Insufficiency, ARDS, pandemic, Corona Virus Infection, Coronavirus
- Medical subject headings
- COVID-19, Pneumonia, Respiratory Distress Syndrome, Lung Diseases, Lung Injury, Respiratory Tract Diseases, Respiratory Insufficiency, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLBS119Biological
Peripheral blood derived autologous CD34+ cells
| Study group | Role | What they receive |
|---|---|---|
| CLBS119 Active Treatment | Experimental | Single administration of CLBS119 Receives: Biological: CLBS119 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Through end of study (6 months)
Secondary outcomes (1)
Change in oxygen saturation
Measured: Change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start5 Oct 2020
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Acute COVID-19 treatments have improved significantly leading to decreased use of ventilatory support. This, coupled with approval of a vaccine, has changed the profile/prognosis of patients and led to a lack of patients with long-term hypoxia.
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisata Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas W Losordo, MD, Study director, Chief Medical Officer, Caladrius Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522817
- Sponsor's protocol ID
- CLBS119-P01
- Status last verified
- Oct 2024
- First submitted
- 20 Aug 2020
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage
- ClinicalTrials.gov ID
- NCT04522817
- Acronym / sponsor ID
- CLBS119-P01
- Conditions
- Covid-19
- Keywords
- Pneumonia, COVID, SARs-CoV-2, Pulmonary Inflammation, Respiratory Distress Syndrome, Lung Diseases, Lung Injury, Respiratory Tract Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Acute COVID-19 treatments have improved significantly leading to decreased use of ventilatory support. This, coupled with approval of a vaccine, has changed the profile/prognosis of patients and led to a lack of patients with long-term hypoxia.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lisata Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 21 Aug 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 clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.
Detailed description
This open-label clinical trial will explore the safety and potential efficacy of peripheral blood derived autologous CD34+ cells for the repair of COVID-19 induced pulmonary damage in adults. Eligible subjects will receive a single administration of CLBS119.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLBS119 Active Treatment | Experimental | Biological: CLBS119Single administration of CLBS119 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Initial diagnosis with COVID-19 based on nasopharyngeal, oropharyngeal, or tracheobronchial aspirate SARS CoV-2 RT-PCR test
- Receiving or received ventilatory support for COVID-19 pneumonia/ARDS
- Evidence for ongoing pulmonary involvement based on P/F ratio <300
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Immunocompromised or current use of immunosuppressive agents other than corticosteroids
- History of autoimmune disease
- Evidence of multiorgan failure
- Subject is pregnant or lactating at the time of signing the consent
- Participation in any other clinical trial of an experimental treatment for COVID-19
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 |
|---|---|---|
| CLBS119Peripheral blood derived autologous CD34+ cells | Biological | CLBS119 Active Treatment |
Primary outcome
Adverse events
Time frame: Through end of study (6 months)
1 secondary outcome
Change in oxygen saturation
Time frame: Change from baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Douglas W Losordo, MD study director
Chief Medical Officer, Caladrius Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLBS119 in people with Covid-19, run by Lisata Therapeutics, Inc. at 1 site 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 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 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Adverse events (time frame: Through end of study (6 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 9 Oct 2024.