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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Biological: PSC-04

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93710
      • Fresno Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sorrento Therapeutics, Inc.
• Collaborators: VetStem Biopharma, Inc.; Fresno Community Hospital and Medical Center

Publications and helpful links

General Publications

• Rogers CJ, Harman RJ, Bunnell BA, Schreiber MA, Xiang C, Wang FS, Santidrian AF, Minev BR. Rationale for the clinical use of adipose-derived mesenchymal stem cells for COVID-19 patients. J Transl Med. 2020 May 18;18(1):203. doi: 10.1186/s12967-020-02380-2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2020
• Primary Completion (ACTUAL): June 9, 2021
• Study Completion (ACTUAL): August 30, 2021

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (ACTUAL): July 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; COVID19; stem cell; pneumonia; adipose
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PSC-CP-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No