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NCT04522817 Clinical Trial

CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

Covid-19 Clinical Trial

Official title:
CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04522817
Other study ID # CLBS119-P01
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date October 5, 2020
Est. completion date May 2021

Study information
Verified date December 2020
Source Caladrius Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.

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 information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• CLBS119
Peripheral blood derived autologous CD34+ cells

Locations
Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)
Lead Sponsor Collaborator
Caladrius Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events Through end of study (6 months)
Secondary Change in oxygen saturation Change from baseline
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