CLBS119 for Repair of COVID-19 Induced Pulmonary Damage | NCT04522817

Studies
CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

NCT04522817

Sponsor

Lisata Therapeutics, Inc.

Status

Withdrawn

Last Update Posted

Oct 9, 2024Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Covid-19

Interventions

CLBS119

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

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.

Expanded Access Info

Start Date

Oct 5, 2020Actual

Primary Completion Date

May 2021Estimated

Completion Date

May 2021Estimated

First Submitted Date

Aug 20, 2020

First Submission Date that Met QC Criteria

Aug 20, 2020

First Posted Date

Aug 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2024

Last Update Posted Date

Oct 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CLBS119 Active Treatment	Experimental	Single administration of CLBS119	Biological: CLBS119

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CLBS119	Biological	Peripheral blood derived autologous CD34+ cells	CLBS119 Active Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events		Through end of study (6 months)

Secondary Outcomes

Measure	Description	Time Frame
Change in oxygen saturation		Change from baseline

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Douglas W Losordo, MD	Chief Medical Officer, Caladrius Biosciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health		New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D011014	Pneumonia
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D055370	Lung Injury
D012140	Respiratory Tract Diseases
D012131	Respiratory Insufficiency
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided