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CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

Primary Purpose

Covid-19

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CLBS119

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring Pneumonia, COVID, SARs-CoV-2, Pulmonary Inflammation, Respiratory Distress Syndrome, Lung Diseases, Lung Injury, Respiratory Tract Diseases, Respiratory Insufficiency, ARDS, pandemic, Corona Virus Infection, Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CLBS119 Active Treatment

Arm Description

Single administration of CLBS119

Outcomes

Primary Outcome Measures

Adverse events

Secondary Outcome Measures

Change in oxygen saturation

Full Information

NCT ID

NCT04522817

First Posted

August 20, 2020

Last Updated

December 14, 2020

Sponsor

Lisata Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04522817

Brief Title

CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Acute COVID-19 treatments have improved significantly leading to decreased use of ventilatory support. This, coupled with approval of a vaccine, has changed the profile/prognosis of patients and led to a lack of patients with long-term hypoxia.

Study Start Date

October 5, 2020 (Actual)

Primary Completion Date

May 2021 (Anticipated)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lisata Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid-19

Keywords

Pneumonia, COVID, SARs-CoV-2, Pulmonary Inflammation, Respiratory Distress Syndrome, Lung Diseases, Lung Injury, Respiratory Tract Diseases, Respiratory Insufficiency, ARDS, pandemic, Corona Virus Infection, Coronavirus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CLBS119 Active Treatment

Arm Type

Experimental

Arm Description

Single administration of CLBS119

Intervention Type

Biological

Intervention Name(s)

CLBS119

Intervention Description

Peripheral blood derived autologous CD34+ cells

Primary Outcome Measure Information:

Title

Adverse events

Time Frame

Through end of study (6 months)

Secondary Outcome Measure Information:

Title

Change in oxygen saturation

Time Frame

Change from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas W Losordo, MD

Organizational Affiliation

Chief Medical Officer, Caladrius Biosciences

Official's Role

Study Director

Facility Information:

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

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