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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
T regulatory cell infusion 		Infusion will be administered to the patient within 72 hours of collection from donor.
  • Biological: T regulatory cells
    T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.

Recruiting Locations

More Details

NCT ID
NCT04737161
Status
Withdrawn
Sponsor
Stanford University

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.