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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PSC-04
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring adipose, stem cell, COVID19, COVID-19, pneumonia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fresno Community Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

This is single arm study with only comparison to non-treated cohorts at site.

Outcomes

Primary Outcome Measures

Frequency of all adverse events
Frequency of all reported adverse events in study
Frequency of infusion related serious adverse events
Frequency of SAEs in the 6 hours post-infusion for each infusion
Frequency of serious adverse events
Frequency of all serious adverse events in study

Secondary Outcome Measures

Mortality
All-cause mortality through Day 28
Ventilator Free Days
Ventilator free days through Study day 28
ICU Free Days
Total days not in ICU from Study day 0 through Study day 28
Total Hospital Days
Total Days in Hospital from Day 0 through discharge for survivors
Total ICU Days
Total Days in ICU from Day 0 through discharge for survivors
Improvement in Oxygenation
Improvement in oxygenation comparing Study day 0, to days 2, 4, 6

Full Information

First Posted
July 22, 2020
Last Updated
March 15, 2022
Sponsor
Sorrento Therapeutics, Inc.
Collaborators
VetStem Biopharma, Inc., Fresno Community Hospital and Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04486001
Brief Title
Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19
Acronym
CoronaStem1
Official Title
COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
June 9, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorrento Therapeutics, Inc.
Collaborators
VetStem Biopharma, Inc., Fresno Community Hospital and Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
adipose, stem cell, COVID19, COVID-19, pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
single group comparison with cohort of contemporaneous non-treated patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
This is single arm study with only comparison to non-treated cohorts at site.
Intervention Type
Biological
Intervention Name(s)
PSC-04
Other Intervention Name(s)
allogeneic, adipose-derived stem cells
Intervention Description
adipose stem cells derived from screened donor lipoaspirate and culture expanded.
Primary Outcome Measure Information:
Title
Frequency of all adverse events
Description
Frequency of all reported adverse events in study
Time Frame
Through study completion, an average of three months
Title
Frequency of infusion related serious adverse events
Description
Frequency of SAEs in the 6 hours post-infusion for each infusion
Time Frame
6 hours post infusion
Title
Frequency of serious adverse events
Description
Frequency of all serious adverse events in study
Time Frame
Through study completion, an average of three months
Secondary Outcome Measure Information:
Title
Mortality
Description
All-cause mortality through Day 28
Time Frame
Study days 0-28
Title
Ventilator Free Days
Description
Ventilator free days through Study day 28
Time Frame
Study days 0-28
Title
ICU Free Days
Description
Total days not in ICU from Study day 0 through Study day 28
Time Frame
Days 0 through 28
Title
Total Hospital Days
Description
Total Days in Hospital from Day 0 through discharge for survivors
Time Frame
Days 0 through discharge, an average of 28 days
Title
Total ICU Days
Description
Total Days in ICU from Day 0 through discharge for survivors
Time Frame
Days 0 through discharge, an average of 28 days
Title
Improvement in Oxygenation
Description
Improvement in oxygenation comparing Study day 0, to days 2, 4, 6
Time Frame
Study days 0, 2, 4, 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD JD
Organizational Affiliation
Sorrento Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Fresno Community Hospital
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32423449
Citation
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.
Results Reference
result

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

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