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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04909879
• Other study ID #: MSC-ARDS-201
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 2021
• Est. completion date: April 2022

Study information

• Verified date: September 2021
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Ards
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Biological:
• COVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

Drug:
• Placebo
Excipient solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality rate at Day 28	All-cause mortality rate at Day 28	Baseline to Day 28
Secondary	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
Secondary	Number of ventilator-free days through Day 28	Number of ventilator-free days through Day 28	Baseline through Day 28
Secondary	Number of ICU days through Day 28	Number of ICU days through Day 28	Baseline through Day 28
Secondary	Clinical status at Day 28	Clinical status as assessed using the Ordinal Scale for Clinical Improvement (0-8 scale, where lower score means better outcome)	Baseline to Day 28
Secondary	Change in oxygenation	Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio.	Baseline to Day 2, Day 4, Day 6, Day 14, Day 28