CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

December 14, 2020 updated by: Lisata Therapeutics, Inc.

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CLBS119 Active Treatment
Single administration of CLBS119
Biological: CLBS119
Peripheral blood derived autologous CD34+ cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Through end of study (6 months)
Through end of study (6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in oxygen saturation
Time Frame: Change from baseline
Change from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisata Therapeutics, Inc.

Investigators

  • Study Director: Douglas W Losordo, MD, Chief Medical Officer, Caladrius Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBS119-P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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