Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19
NCT04486001 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2022-03-17
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.
Conditions
- Covid19
Interventions
- BIOLOGICAL
-
PSC-04
adipose stem cells derived from screened donor lipoaspirate and culture expanded.
Sponsors & Collaborators
-
VetStem Biopharma, Inc.
collaborator UNKNOWN -
Fresno Community Hospital and Medical Center
collaborator OTHER -
Sorrento Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Mike Royal, MD JD · Sorrento Therapeutics, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-15
- Primary Completion
- 2021-06-09
- Completion
- 2021-08-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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