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

NCT ID: NCT04486001

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2021-08-30

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.

Conditions

Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

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

Group Type: EXPERIMENTAL

PSC-04

Intervention Type: BIOLOGICAL

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

Interventions

PSC-04

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

Intervention Type: BIOLOGICAL

Other Intervention Names

allogeneic, adipose-derived stem cells

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VetStem Biopharma, Inc.

UNKNOWN

Sponsor Role: collaborator

Fresno Community Hospital and Medical Center

OTHER

Sponsor Role: collaborator

Sorrento Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike Royal, MD JD

Role: STUDY_DIRECTOR

Sorrento Therapeutics, Inc.

Locations

Fresno Community Hospital

Fresno, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 32423449 (View on PubMed)

Other Identifiers

PSC-CP-004

Identifier Type: -

Identifier Source: org_study_id