Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Covid19 adipose stem cell COVID-19 pneumonia PSC-04

Eligibility

You can join if…

Open to people ages 18-80

  • 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

You CAN'T join if...

  • 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.

Location

  • Fresno Community Hospital
    Fresno California 93703 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Sorrento Therapeutics, Inc.
ID
NCT04486001
Phase
Phase 1
Study Type
Interventional
Last Updated