Safety and Efficacy of CAStem for Severe COVID-19 Associated With/Without ARDS

General Information
Summary	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.
Description	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.
Clinical trials phase	Phases 1/2
Start date (estimated)	2020-01-27
End date (estimated)	2020-12-31
Clinical feature	Label COVID-19 Link http://purl.obolibrary.org/obo/DOID_0080600 Description A Coronavirus infectious disease that is characterized by fever, cough and shortness of breath and that has_material_basis_in SARS-CoV-2.
Administrative Information
NCT number	NCT04331613
ICTRP weblink	https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04331613
Other study identifiers	Name ChineseASZQ-006
Source weblink	https://clinicaltrials.gov/ct2/show/NCT04331613
Public contact	Email wangliu@ioz.ac.cn Public email wangliu@ioz.ac.cn First name Liu Last name Wang Country China
Sponsors	Chinese Academy of Sciences
Cells
Which differentiated cell type is used	Label mesenchymal stem cell Link http://purl.obolibrary.org/obo/CL_0000134 Description A connective tissue cell that normally gives rise to other cells that are organized as three-dimensional masses. In humans, this cell type is CD73-positive, CD90-positive, CD105-positive, CD45-negative, CD34-negative, and MHCII-negative. They may further differentiate into osteoblasts, adipocytes, myocytes, neurons, or chondroblasts in vitro. Originally described as residing in the bone marrow, this cell type is now known to reside in many, if not all, adult organs.; Many but not all mesenchymal cells derive from the mesoderm. MSCs are reportedly CD3-negative, CD4-negative, CD5-negative, CD8-negative, CD11a-negative, CD11b-negative, CD14-negative, CD19-negative, CD29-positive, CD31-negative, CD34-negative, CD38-negative, CD40-negative, CD44-positive, CD45-negative, CD49-positive, CD54-positive, CD66b-negative, CD79a-negative, CD80-negative, CD102-positive, CD106-positive, CD117-positive, CD121a-positive, CD121b-positive, CD123-positive, CD124-positive, CD133-negative, CD146-positive, CD166-positive, CD271-positive, B220-negative, Gr1-negative, MHCI-positive, MHCII-negative, SSEA4-negative, sca1-positive, Ter119-negative, and glycophorin A-negative. Cultured MSCs are capable of producing stem cell factor, IL7, IL8, IL11, TGF-beta, cofilin, galectin-1, laminin-receptor 1, cyclophilin A, and MMP-2.
Recruitment
Recruitment Status	Unknown Status
Estimated number of participants	9