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

Covid19 Clinical Trial

— CoronaStem1  

Official title:

COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486001
• Other study ID #: PSC-CP-004
• Status: Completed
• Phase: Phase 1
• Start date: December 15, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: March 2022
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• PSC-04
adipose stem cells derived from screened donor lipoaspirate and culture expanded.

Locations

Country	Name	City	State
United States	Fresno Community Hospital	Fresno	California

Sponsors (3)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.	Fresno Community Hospital and Medical Center, VetStem Biopharma, Inc.

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of all adverse events	Frequency of all reported adverse events in study	Through study completion, an average of three months
Primary	Frequency of infusion related serious adverse events	Frequency of SAEs in the 6 hours post-infusion for each infusion	6 hours post infusion
Primary	Frequency of serious adverse events	Frequency of all serious adverse events in study	Through study completion, an average of three months
Secondary	Mortality	All-cause mortality through Day 28	Study days 0-28
Secondary	Ventilator Free Days	Ventilator free days through Study day 28	Study days 0-28
Secondary	ICU Free Days	Total days not in ICU from Study day 0 through Study day 28	Days 0 through 28
Secondary	Total Hospital Days	Total Days in Hospital from Day 0 through discharge for survivors	Days 0 through discharge, an average of 28 days
Secondary	Total ICU Days	Total Days in ICU from Day 0 through discharge for survivors	Days 0 through discharge, an average of 28 days
Secondary	Improvement in Oxygenation	Improvement in oxygenation comparing Study day 0, to days 2, 4, 6	Study days 0, 2, 4, 6