Clinical trial NCT04486001: Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19
Official title: COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Keywords: adipose
stem cell
COVID19
COVID-19
pneumonia
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: VetStem Biopharma, Inc.
name: Fresno Community Hospital and Medical Center
First posted: 2020-07-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group comparison with cohort of contemporaneous non-treated patients.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Frequency of all adverse events
timeFrame: Through study completion, an average of three months
measure: Frequency of infusion related serious adverse events
timeFrame: 6 hours post infusion
measure: Frequency of serious adverse events
timeFrame: Through study completion, an average of three months
Secondary outcomes:
measure: Mortality
timeFrame: Study days 0-28
measure: Ventilator Free Days
timeFrame: Study days 0-28
measure: ICU Free Days
timeFrame: Days 0 through 28
measure: Total Hospital Days
timeFrame: Days 0 through discharge, an average of 28 days
measure: Total ICU Days
timeFrame: Days 0 through discharge, an average of 28 days
measure: Improvement in Oxygenation
timeFrame: Study days 0, 2, 4, 6
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Fresno Community Hospital
state: California
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD JD
role: STUDY_DIRECTOR
References:
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.