CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

Lisata Therapeutics, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Covid-19

Interventions

CLBS119BIOLOGICAL

Peripheral blood derived autologous CD34+ cells

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Adverse events

Time frame: Through end of study (6 months)

Secondary Outcomes

Change in oxygen saturation

Time frame: Change from baseline

Data from ClinicalTrials.gov

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