Covid19
Conditions
Keywords
adipose, stem cell, COVID19, COVID-19, pneumonia
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.
Interventions
BIOLOGICALPSC-04
adipose stem cells derived from screened donor lipoaspirate and culture expanded.
Sponsors
VetStem Biopharma, Inc.
Fresno Community Hospital and Medical Center
Sorrento Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single group comparison with cohort of contemporaneous non-treated patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of all adverse events | Through study completion, an average of three months | Frequency of all reported adverse events in study |
| Frequency of infusion related serious adverse events | 6 hours post infusion | Frequency of SAEs in the 6 hours post-infusion for each infusion |
| Frequency of serious adverse events | Through study completion, an average of three months | Frequency of all serious adverse events in study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Hospital Days | Days 0 through discharge, an average of 28 days | Total Days in Hospital from Day 0 through discharge for survivors |
| Mortality | Study days 0-28 | All-cause mortality through Day 28 |
| Improvement in Oxygenation | Study days 0, 2, 4, 6 | Improvement in oxygenation comparing Study day 0, to days 2, 4, 6 |
| Total ICU Days | Days 0 through discharge, an average of 28 days | Total Days in ICU from Day 0 through discharge for survivors |
| Ventilator Free Days | Study days 0-28 | Ventilator free days through Study day 28 |
| ICU Free Days | Days 0 through 28 | Total days not in ICU from Study day 0 through Study day 28 |
Countries
United States
Outcome results
None listed