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

Sorrento Therapeutics, Inc.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Acute Respiratory Distress Syndrome Ards

Interventions

COVI-MSCBIOLOGICAL

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

PlaceboDRUG

Excipient solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

All-cause mortality rate at Day 28

Time frame: Baseline to Day 28

Secondary Outcomes

All-cause mortality rate at Days 60 and 90

Time frame: Baseline to Day 60 and Day 90

Number of ventilator-free days through Day 28

Time frame: Baseline through Day 28

Number of ICU days through Day 28

Time frame: Baseline through Day 28

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)

Time frame: Baseline to Day 28

Change in oxygenation

Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio.

Time frame: Baseline to Day 2, Day 4, Day 6, Day 14, Day 28

Data from ClinicalTrials.gov

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