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

Phase 1

Completed

• Conditions: Covid19
• Interventions: Biological: PSC-04

• Registration Number: NCT04486001
• Lead Sponsor: Sorrento Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-24
• Study Start: 2020-12-15
• Primary Completion: 2021-06-09
• Study Completion: 2021-08-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	PSC-04	This is single arm study with only comparison to non-treated cohorts at site.

Primary Outcome Measures

Name	Time	Method
Frequency of all adverse events	Through study completion, an average of three months	Frequency of all reported adverse events in study
Frequency of serious adverse events	Through study completion, an average of three months	Frequency of all serious adverse events in study
Frequency of infusion related serious adverse events	6 hours post infusion	Frequency of SAEs in the 6 hours post-infusion for each infusion

Secondary Outcome Measures

Name	Time	Method
Mortality	Study days 0-28	All-cause mortality through Day 28
ICU Free Days	Days 0 through 28	Total days not in ICU from Study day 0 through Study day 28
Total ICU Days	Days 0 through discharge, an average of 28 days	Total Days in ICU from Day 0 through discharge for survivors
Ventilator Free Days	Study days 0-28	Ventilator free days through Study day 28
Total Hospital Days	Days 0 through discharge, an average of 28 days	Total Days in Hospital from Day 0 through discharge for survivors
Improvement in Oxygenation	Study days 0, 2, 4, 6	Improvement in oxygenation comparing Study day 0, to days 2, 4, 6

Trial Locations

Locations (1)

Fresno Community Hospital; 🇺🇸 Fresno, California, United States