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

• Status: Withdrawn
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sorrento Therapeutics, Inc.

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