CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

NCT ID: NCT04522817

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Covid-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CLBS119 Active Treatment

Single administration of CLBS119

Group Type EXPERIMENTAL

CLBS119

Intervention Type BIOLOGICAL

Peripheral blood derived autologous CD34+ cells

Interventions

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CLBS119

Peripheral blood derived autologous CD34+ cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lisata Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas W Losordo, MD

Role: STUDY_DIRECTOR

Chief Medical Officer, Caladrius Biosciences

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CLBS119-P01

Identifier Type: -

Identifier Source: org_study_id

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