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.
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.
Biological: PSC-04
adipose stem cells derived from screened donor lipoaspirate and culture expanded.
Other Name: allogeneic, adipose-derived stem cells
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.
Fresno Community Hospital
Fresno, California, United States
Mike Royal, MD JD, Study Director
Sorrento Therapeutics, Inc.