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

Purpose

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.

Condition

  • Covid19

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Admitted to hospital as in-patient (ward or ICU) - Respiratory distress - respiratory rate ≥ 30/minute (or PaO2:FiO2 <300) - Bilateral lung infiltrates (CT or frontal X-ray) - Supplemental oxygen started but NOT intubated or ventilated - COVID-19 (SARS-CoV-2) antigen test positive (FDA-approved test); - CDC confirmation not necessary - Time from Enrollment to treatment must be less than 24 hours - Age: 18-80 years - Gender: any - Suitability for cellular therapy: In the opinion of the Investigator or the Sponsor the patient is suitable for cellular therapy - Cognitive function: Able to understand and willing to sign informed consent form or legally authorized representative or surrogate

Exclusion Criteria

  • Intubation / ventilation - Current therapy is working, and patient is clinically improving - Disease Conditions: Heart failure severe (NY Heart Association Classification IV); Clinical evidence of left heart failure or volume overload as a primary explanation for the bilateral pulmonary infiltrates; Any disease or condition other than current respiratory COVID-19 disease for which 6-month mortality is estimated to be greater than 50%; Moderate to severe liver failure; Severe chronic respiratory disease or the use of home oxygen use prior to this current illness; Currently receiving extracorporeal life support (ECLS/ECMO) - Past Disease Conditions: Any history of malignancy within the last 2 years (except for patients in remission or cured of the malignancy); Lung transplant patient or lobectomy; Deep venous thrombosis or pulmonary embolism within past 3 months; History of splenectomy - Other Experimental Conditions: Currently enrolled or treated in last 60 days in another clinical study - Consent Issues: Do not resuscitate (DNR) order in place; Not willing to follow lung protective ventilation strategy, if needed - Concurrent disease or circumstances that Investigator or Sponsor judges to be an unacceptable risk to patient health or a confounding variable to assessment or problem in completion of trial.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
single group comparison with cohort of contemporaneous non-treated patients.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Group 		This is single arm study with only comparison to non-treated cohorts at site.
  • Biological: PSC-04
    adipose stem cells derived from screened donor lipoaspirate and culture expanded.
    Other names:
    • allogeneic, adipose-derived stem cells

Recruiting Locations

More Details

NCT ID
NCT04486001
Status
Completed
Sponsor
Sorrento Therapeutics, Inc.

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.