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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486001
Recruitment Status : Not yet recruiting
First Posted : July 24, 2020
Last Update Posted : November 6, 2020
Sponsor:
Collaborators:
VetStem Biopharma, Inc.
Fresno Community Hospital and Medical Center
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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.

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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
Estimated Study Start Date : December 15, 2020
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486001


Contacts
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Contact: Susan P Harman, BS 858-748-2004 sharman@vetstem.com
Contact: Robert J Harman, DVM, MPVM 858-748-2004 bharman@vetstem.com

Locations
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United States, California
Fresno Community Hospital
Fresno, California, United States, 93703
Contact: Rebekah Garcia, CCRP    559-499-6636    rgarcia@fresno.ucsf.edu   
Contact: Christine Mergillano, BS, CCRP    559-499-6639    cmergillano@fresno.ucsf.edu   
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
VetStem Biopharma, Inc.
Fresno Community Hospital and Medical Center
Investigators
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Principal Investigator: Christopher Rogers, MD Personalized Stem Cells, Inc.
Publications of Results:
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04486001    
Other Study ID Numbers: PSC-CP-004
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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