Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Biological: T regulatory cells

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305