CLBS119 for Repair of COVID-19 Induced Pulmonary Damage
Purpose
This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.
Condition
- Covid-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CLBS119 Active Treatment |
Single administration of CLBS119 |
|
Recruiting Locations
More Details
- NCT ID
- NCT04522817
- Status
- Withdrawn
- Sponsor
- Lisata Therapeutics, Inc.
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.