Covid-19
Conditions
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
Brief summary
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.
Interventions
BIOLOGICALCLBS119
Peripheral blood derived autologous CD34+ cells
Sponsors
Lisata Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | Through end of study (6 months) |
Secondary
| Measure | Time frame |
|---|---|
| Change in oxygen saturation | Change from baseline |
Countries
United States
Outcome results
None listed