Study 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.
CLBS119 for Repair of COVID-19 Induced Pulmonary Damage
CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedStudy Start
First participant enrolled
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedOctober 9, 2024
October 1, 2024
7 months
August 20, 2020
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
Through end of study (6 months)
Secondary Outcomes (1)
Change in oxygen saturation
Change from baseline
Study Arms (1)
CLBS119 Active Treatment
EXPERIMENTALSingle administration of CLBS119
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Douglas W Losordo, MD
Chief Medical Officer, Caladrius Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 21, 2020
Study Start
October 5, 2020
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
October 9, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share