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

• ClinicalTrials.gov Identifier: NCT04486001
• Recruitment Status: Recruiting
• First Posted: July 24, 2020
• Last Update Posted: February 2, 2021
• Sponsor: Sorrento Therapeutics, Inc.
• Collaborators: VetStem Biopharma, Inc.; Fresno Community Hospital and Medical Center
• Information provided by (Responsible Party): Sorrento Therapeutics, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Covid19	Biological: PSC-04	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single group comparison with cohort of contemporaneous non-treated patients.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells
• Actual Study Start Date: December 15, 2020
• Estimated Primary Completion Date: January 15, 2022
• Estimated Study Completion Date: January 15, 2022

Arms and Interventions

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 Name: allogeneic, adipose-derived stem cells

Outcome Measures

Primary Outcome Measures :

1. Frequency of all adverse events [ Time Frame: Through study completion, an average of three months ]
   Frequency of all reported adverse events in study
2. Frequency of infusion related serious adverse events [ Time Frame: 6 hours post infusion ]
   Frequency of SAEs in the 6 hours post-infusion for each infusion
3. Frequency of serious adverse events [ Time Frame: Through study completion, an average of three months ]
   Frequency of all serious adverse events in study

Secondary Outcome Measures :

1. Mortality [ Time Frame: Study days 0-28 ]
   All-cause mortality through Day 28
2. Ventilator Free Days [ Time Frame: Study days 0-28 ]
   Ventilator free days through Study day 28
3. ICU Free Days [ Time Frame: Days 0 through 28 ]
   Total days not in ICU from Study day 0 through Study day 28
4. Total Hospital Days [ Time Frame: Days 0 through discharge, an average of 28 days ]
   Total Days in Hospital from Day 0 through discharge for survivors
5. Total ICU Days [ Time Frame: Days 0 through discharge, an average of 28 days ]
   Total Days in ICU from Day 0 through discharge for survivors
6. Improvement in Oxygenation [ Time Frame: Study days 0, 2, 4, 6 ]
   Improvement in oxygenation comparing Study day 0, to days 2, 4, 6

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Mike Royal, MD JD; 858-203-4100; mroyal@sorrentotherapeutics.com

Locations

United States, California

Fresno Community Hospital; Recruiting

Fresno, California, United States, 93710

Contact: Rebekah Garcia, CCRP 559-499-6636 rgarcia@fresno.ucsf.edu

Contact: Christine Mergillano, BS, CCRP 559-499-6639 cmergillano@fresno.ucsf.edu

Principal Investigator: Eyad Almasri, MD

Sponsors and Collaborators

Sorrento Therapeutics, Inc.

VetStem Biopharma, Inc.

Fresno Community Hospital and Medical Center

Investigators

• Study Director: Mike Royal, MD JD; Sorrento Therapeutics, Inc.

More Information

Publications of Results:

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. Review.

• Responsible Party: Sorrento Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04486001
• Other Study ID Numbers: PSC-CP-004
• First Posted: July 24, 2020
• Last Update Posted: February 2, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sorrento Therapeutics, Inc.:

adipose; stem cell; COVID19; COVID-19; pneumonia