Study of Allogeneic Adipose-Derived Mesenchymal Stem Cell... | NCT04909879

Studies
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome

NCT04909879

Sponsor

Sorrento Therapeutics, Inc.

Status

Withdrawn

Last Update Posted

Sep 24, 2021Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Acute Respiratory Distress Syndrome
Ards

Interventions

COVI-MSC
Placebo

Countries

Not provided

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

Sep 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Replaced by a different protocol.

Expanded Access Info

Start Date

Sep 2021Estimated

Primary Completion Date

Feb 2022Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

May 29, 2021

First Submission Date that Met QC Criteria

May 29, 2021

First Posted Date

Jun 2, 2021Actual

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

Sep 17, 2021

Last Update Posted Date

Sep 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.

Detailed Description

This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.

Subjects will be randomized 2:1 to receive COVI-MSC or placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

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 2

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
COVI-MSC	Experimental	Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4	Biological: COVI-MSC
Placebo	Placebo Comparator	Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVI-MSC	Biological	COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells	COVI-MSC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality rate at Day 28	All-cause mortality rate at Day 28	Baseline to Day 28

Secondary Outcomes

Measure	Description	Time Frame
All-cause mortality rate at Days 60 and 90	All-cause mortality rate at Days 60 and 90	Baseline to Day 60 and Day 90
Number of ventilator-free days through Day 28	Number of ventilator-free days through Day 28

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300
Requires oxygen supplementation at Screening
Willing to follow contraception guidelines

Exclusion Criteria:

Current standard of care treatments for ARDS appear to be working and the subject is clinically improving
A previous stem cell infusion unrelated to this trial
Pregnant or breast feeding or planning for either during the study
Suspected uncontrolled active bacterial, fungal, viral, or other infection
History of a splenectomy, lung transplant or lung lobectomy
Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days

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

Name	Affiliation	Role
Mike Royal, MD	Sorrento Therapeutics, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome
D055371	Acute Lung Injury

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D055370	Lung Injury

Browse Leaves

Not provided

Browse Branches

Not provided