Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19 (CoronaStem1)

Sorrento Therapeutics

Status and phase

Completed

Phase 1

Conditions

Covid19

Treatments

Biological: PSC-04

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04486001

PSC-CP-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.