A phase1/2, open label, dose escalation, safety and early efficacy study of CAStem for the treatment of severe COVID-19 associated with or without ARDS.
CAStem is an injectable product composed of immunity- and matrix-regulatory cells (IMRCs), also named M cells, differentiated from clinical-grade human embryonic stem cells (hESCs) will be expanded, harvested, and formulated at a concentration of 50 x 10\^6 cells/mL. CAStem will be cryopreserved and transported to clinical site using liquid nitrogen vapor shipping vessels (\< -150ºC). Prior to injection, CAStem will be thawed to liquefy quickly, and then reconstituted in normal saline.In the present study, the intravenous infusion dose of CAStem will be 3, 5 or 10 million cells/kg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
CAStem will be administered intravenously.
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing, China, China
RECRUITINGAdverse reaction (AE) and severe adverse reaction (SAE)
Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment
Time frame: Within 28 days after treatment
Changes of lung imaging examinations
Evaluation by chest CT
Time frame: Within 28 days after treatment
Time to SARS-CoV-2 RT-PCR negative
Marker for SARS-CoV-2
Time frame: Within 28 days after treatment
Duration of fever (Celsius)
The duration of a fever above 37.3 degrees Celsius
Time frame: Within 28 days after treatment
Changes of blood oxygen (%)
Marker for efficacy
Time frame: Within 28 days after treatment
Rate of all-cause mortality within 28 days
Marker for efficacy
Time frame: Within 28 days after treatment
Lymphocyte count (*10^9/L)
Counts of lymphocyte in a litre (L) of blood
Time frame: Within 28 days after treatment
Alanine aminotransferase (U/L)
Alanine aminotransferase in unit (U)/litre(L)
Time frame: Within 28 days after treatment
Creatinine (umol/L)
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Creatinine in micromole (umol)/litre(L)
Time frame: Within 28 days after treatment
Creatine kinase (U/L)
Creatine kinase in U/L
Time frame: Within 28 days after treatment
C-reactive protein (mg/L)
C-reactive in microgram (mg)/litre(L)
Time frame: Within 28 days after treatment
Procalcitonin (ng/L)
Procalcitonin in nanogram (ng)/litre(L)
Time frame: Within 28 days after treatment
Lactate (mmol/L)
Lactate in millimole(mmol)/litre(L)
Time frame: Within 28 days after treatment
IL-1beta (pg/mL)
IL-1beta in picogram(pg)/millilitre(mL)
Time frame: Within 28 days after treatment
IL-2 (pg/mL)
IL-2 in pg/mL
Time frame: Within 28 days after treatment
IL-6 (pg/mL)
IL-6 in pg/mL
Time frame: Within 28 days after treatment
IL-8 (pg/mL)
IL-8 in pg/mL
Time frame: Within 28 days after treatment