This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS. Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.
Biological: T regulatory cells
T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.
Inclusion Criteria:
- Age 18 years to 75 years
- All patients at entry are required to be at high risk for the development of ARDS or
receiving mechanical ventilatory support
- Provision of signed written informed consent from the patient or patients legally
authorized representative
- Only patients who are committed to full life support (Do not resuscitate (DNR)
allowed)
- Initiation of study drug within 120 hours of the diagnosis of acute lung injury
(ALI)/ARDS
- COVID positive by PCR testing
Exclusion Criteria:
- Concurrent illness that shortens life expectancy to less than 6 months
- Inability to obtain adequate study follow-up
- Greater than 90 hours since first meeting ARDS criteria per the Berlin definition
Stanford University
Stanford, California, United States
Joe L Hsu, MD, Principal Investigator
Stanford University