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CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522817
Recruitment Status : Withdrawn (Acute COVID-19 treatments have improved significantly leading to decreased use of ventilatory support.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.)
First Posted : August 21, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Caladrius Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Covid-19 Biological: CLBS119 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


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




Primary Outcome Measures :
  1. Adverse events [ Time Frame: Through end of study (6 months) ]

Secondary Outcome Measures :
  1. Change in oxygen saturation [ Time Frame: Change from baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522817


Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
Caladrius Biosciences, Inc.
Investigators
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Study Director: Douglas W Losordo, MD Chief Medical Officer, Caladrius Biosciences
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Responsible Party: Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04522817    
Other Study ID Numbers: CLBS119-P01
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caladrius Biosciences, Inc.:
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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases