This study is to explore the safety and efficacy of using UCMSC01 in patients with COVID-19 infection via IV stem cell administration. The novelty of the current UMSC01 treatment is the single IV infusion of UMSC01 to the worldwide emergency outbreaks of COVID-19. We hypothesize that sufficient UMSC01 retention in lung may modulate the systemic inflammatory responses.
The lead Phase I safety phase will further confirm the safety profile of UMSC01 in 5 COVID-19 patients each at two dose regimens and placebo. To start the Phase IIa study, data analysis will be performed as soon as the 21-day treatment period has been completed in the three groups. With considerations of the pandemic status and clinical practice, only one of the two active treatment groups will be selected to complete the Phase IIa study, which will recruit 60 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
UMSC01 cells will be IV infusion with 12 months of follow up after treatment.
Normal saline will be IV infusion with 12 months of follow up after treatment.
China Medical University Hospital
Taichung, Non-US, Taiwan
Two Co-Primary Efficacy Endpoints
Proportion of patients alive with sustained improvement within the 21 days of the treatment period (Proportion Analysis), which indicates the capability of UMSC01 to save more lives
Time frame: 21 days of the treatment period
Two Co-Primary Efficacy Endpoints
Time (days) to reach sustained improvement within the 21 days of the treatment period (Time-to-Event Analysis), which indicates the capability of UMSC01 to enable patients to less suffer from the disease condition.
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Proportion of enrolled patients alive on Day 21
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Proportion of enrolled patients alive and free of respiratory failure on Day 21
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Improvement of COVID 19 pneumonia confirmed by chest radiographs or computed tomography on Day 21 or on the day of discharge compared with baseline
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Improvement of clinical symptoms including duration of fever in degrees C and respiratory failure on Day 21 or on the day of discharge compared with baseline
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Duration of ventilator usage or oxygen therapy on Day 21 or on the day of discharge compared with baseline
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Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Levels of tumor necrosis factor-alpha (TNF-α) in pg/ml, interleukin-6 (IL-6) in pg/ml and interleukin-10 (IL-10) in pg/ml, and C-reactive protein (hsCRP) in mg/dl on Day 21 or on the day of discharge compared to baseline
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Troponin I level as assessed via serum blood samples on Day 21 or on the day of discharge compared with baseline
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
ICU admission rate on Day 21 or on the day of discharge with historical data
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Percentage of subjects recorded in each severity rating based on Clinical classification of the COVID-19 (NCOSS scores from 1 to 8;higher scores mean a worse outcome) on Day 14 compared with historical data
Time frame: 14 days of the treatment period
Secondary Efficacy Endpoints
Percentage of subjects recorded in each severity rating based on Clinical classification of the COVID-19 (NCOSS scores from 1 to 8;higher scores mean a worse outcome) on Day 21 compared with historical data
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Average time (days) for which the patients are alive and free of respiratory failure during the treatment period
Time frame: through study completion, an average of 1 year
Secondary Efficacy Endpoints
Proportion of patients who need ICU care on Day 21 based on the clinical indicative of admission to ICU
Time frame: 21 days of the treatment period
Secondary Efficacy Endpoints
Proportion of patients who has been discharged form hospital on Day 21
Time frame: 21 days of the treatment period
Secondary Safety Endpoints
Number of Participants with infusion-related and allergic reactions during the treatment period
Time frame: 21 days of the treatment period
Secondary Safety Endpoints
Secondary infection, treatment emergent adverse event (TEAE), serious adverse event (SAE), and suspected and unexpected serious adverse reaction (SUSAR) incidences over the study period. The toxicities will be assessed by CTCAE V5.0 during the whole study period (380 days)
Time frame: through study completion, an average of 1 year