Recent Updates
Recently added Catalysts

PSC-04

Phase 1

Covid19 | Biologics | Infectious Disease |Sorrento Therapeutics, Inc.|Trials Updated: Mar 17, 2022

PSC-04 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

PSC-04 clinical trials

PSC-04 · 1 trial · 1 indication

Phase 1 1
NCT04486001Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19Covid19
COMPLETED10 Analytics
PHASE1COMPLETED
Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19
Covid19Unlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Mortality
Study days 0-28
Ventilator Free Days
Study days 0-28
ICU Free Days
Days 0 through 28
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment GroupEXPERIMENTALThis is single arm study with only comparison to non-treated cohorts at site.

Interventions

NameTypeDescription
PSC-04BIOLOGICALadipose stem cells derived from screened donor lipoaspirate and culture expanded.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 pos...

Countries:United States
Unlock Eligibility Criteria