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Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

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)

NCT04737161•Stanford University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Stanford University

Stanford, California, United States

Key Dates

Start Date

March 1, 2021

Primary Completion Date

September 1, 2022

Completion Date

September 1, 2022

Last Updated

April 19, 2021

Conditions

Acute Respiratory Distress SyndromeCovid19

Interventions

T regulatory cells

BIOLOGICAL

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

NCT07450846

Acute Respiratory Distress SyndromeRight Heart Failure

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RECRUITING

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

NCT07414056

Acute Respiratory Distress Syndrome (ARDS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

Assessment of Airway Opening Pressure in Invasively Ventilated Children

Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury

The Effect of the Covid-19 Pandemic Among Operated Patients