NCT04737161

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

A Phase 1 Study to Assess the Safety of Living Related Donor Derived T Regulatory Cell Therapy in Subjects With COVID 19 Induced Acute Respiratory Distress Syndrome (ARDS)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
BIOLOGICAL	T regulatory cells	T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-02-03
• Last updated: 2021-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study