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

NCT04486001 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PSC-CP-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Mortality

  Study days 0-28

• Ventilator Free Days

  Study days 0-28

• ICU Free Days

  Days 0 through 28

• Total Hospital Days

  Days 0 through discharge, an average of 28 days

• Total ICU Days

  Days 0 through discharge, an average of 28 days

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Biological: PSC-04

Interventions

PSC-04 BIOLOGICAL

adipose stem cells derived from screened donor lipoaspirate and culture expanded.

Also known as: allogeneic, adipose-derived stem cells

Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead
• VetStem Biopharma, Inc.: collaborator
• Fresno Community Hospital and Medical Center: collaborator

Study Sites (1)

Fresno Community Hospital

Fresno, California, 93710, United States

Location

Related Publications (1)

• 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.

  PMID: 32423449 RESULT

MeSH Terms

Conditions

COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Royal, MD JD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single group comparison with cohort of contemporaneous non-treated patients.

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 24, 2020
• Study Start: December 15, 2020
• Primary Completion: June 9, 2021
• Study Completion: August 30, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)