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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Biological: PSC-04


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single group comparison with cohort of contemporaneous non-treated patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>This is single arm study with only comparison to non-treated cohorts at site. | Biological: PSC-04<br>* adipose stem cells derived from screened donor lipoaspirate and culture expanded.<br>* Other names: allogeneic, adipose-derived stem cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of all adverse events | Frequency of all reported adverse events in study | Through study completion, an average of three months | 
| Frequency of infusion related serious adverse events | Frequency of SAEs in the 6 hours post-infusion for each infusion | 6 hours post infusion | 
| Frequency of serious adverse events | Frequency of all serious adverse events in study | Through study completion, an average of three months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adipose, stem cell, COVID19, COVID-19, pneumonia