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Withdrawn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
Sponsored by
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
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Withdrawn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
No
Data Monitoring Committee
No
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
No
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
No
Learn more about this trial
CLBS119 for Repair of COVID-19 Induced Pulmonary Damage
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