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

Sorrento Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Acute Respiratory Distress Syndrome; Ards

Treatments: Biological: COVI-MSC; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04909879

MSC-ARDS-201

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

COVI-MSC

Experimental group

Description:

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

Treatment:

Biological: COVI-MSC

Placebo

Placebo Comparator group

Description:

Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4

Treatment:

Drug: Placebo