NCT04331613

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

Safety and Efficacy Study of Human Embryonic Stem Cells Derived M Cells (CAStem) for the Treatment of Severe COVID-19 Associated With or Without Acute Respiratory Distress Syndrome (ARDS)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Chinese Academy of Sciences · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• COVID-19
• Acute Respiratory Distress Syndrome
• Virus; Pneumonia
• Acute Lung Injury

Interventions

Type	Name	Description
BIOLOGICAL	CAStem	CAStem will be administered intravenously.

Timeline

• Start date: 2020-01-27
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-04-02
• Last updated: 2020-04-02

Locations

1 site across 1 country: China