Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome

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

  • Acute Respiratory Distress Syndrome
  • Covid19

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Withdrawn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