CLBS119 for Repair of COVID-19 Induced Pulmonary Damage
- Registration Number
- NCT04522817
- Lead Sponsor
- Lisata Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CLBS119 Active Treatment CLBS119 Single administration of CLBS119
- Primary Outcome Measures
Name Time Method Adverse events Through end of study (6 months)
- Secondary Outcome Measures
Name Time Method Change in oxygen saturation Change from baseline
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States
NYU Langone Health🇺🇸New York, New York, United States