NCT04486001

Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19

COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA.

Detailed description

This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. Study Objectives: Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 disease and respiratory distress. Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	PSC-04	adipose stem cells derived from screened donor lipoaspirate and culture expanded.

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-06-09
• Completion: 2021-08-30
• First posted: 2020-07-24
• Last updated: 2022-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study