This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.
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.
Biological: CLBS119
Peripheral blood derived autologous CD34+ cells
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
NYU Langone Health
New York, New York, United States
Douglas W Losordo, MD, Study Director
Chief Medical Officer, Caladrius Biosciences