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

ArmDescriptionAssigned Intervention
Experimental
CLBS119 Active Treatment 		Single administration of CLBS119
  • Biological: CLBS119
    Peripheral blood derived autologous CD34+ cells

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Withdrawn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.