Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome (THYTECH2)

Launched by HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial, called THYTECH2, is studying a type of cell therapy using specialized immune cells called Treg cells, which are taken from thymic tissue. The goal is to see if these cells can help control excessive inflammation caused by COVID-19 or Acute Respiratory Distress Syndrome (ARDS). This inflammation can lead to serious health issues, and researchers hope that by using these Treg cells, they can restore balance to the immune system and protect the lungs from damage.

To participate in this trial, individuals must be between 18 and 65 years old and have specific signs of respiratory failure due to lung injury. They should also have certain markers of inflammation in their blood. Those who are pregnant, have severe obesity, or certain underlying health issues may not be eligible. Participants will be closely monitored during the study to ensure their safety. This could be an important step in finding new treatments for people suffering from severe symptoms of COVID-19 or ARDS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient over 18 to 65 years of age
• • 2. Patient Informed and non-opposed to the research by his medical doctor during hospitalization
• 3. Patient with clinical, radiological, gasometric and immunological criteria defined as:
• • 1. Acute respiratory failure secondary to acute lung injury of noncardiogenic cause
• • 2. Pulmonary abnormalities compatible with bilateral alveoloinsterstitial infiltrates by chest imaging (radiograph or scan)
• • 3. PaO2/FiO2≤ 300 Presence of at least one of the following markers of inflammation: IL6 \> 40 pg/ml or ferritin \>300 ng/ml or CRP \>3 mg/dl or increasing over the last 24 hours
• Exclusion Criteria:
• • 1. Pregnancy or breast feeding
• • 2. Body mass index \>35
• • 3. Patients not expected to survive 48 hours after enrolment based on clinical assessment
• • 4. Patients with an extracorporeal respiratory support
• • 5. Neutropenia (absolute neutrophil count \<1000/uL)
• • 6. Thrombocytopenia (absolute neutrophil count \<50000/uL)
• • 7. Positive serology for HBV, HCV, or HIV at Screening
• • 8. Life expectancy of less than 6 months due to other pathologies
• • 9. History of significant underlying pulmonary disease requiring oxygen therapy prior to inclusion.
• • 10. Patients with a history of autoimmune diseases
• • 11. Patients with a history of hematopoietic neoplasia or oncology disease
• • 12. Patients with a history of hematopoietic or solid organ transplant
• • 13. Patients with a congenital or induced immunodeficiency
• • 14. Patients received thymoglobulin, basiliximab or any anti-T-cell therapies within 6 moths prior to the screening visit
• • 15. Patients received other cell therapy in the last 12 months
• • 16. Patients received intravenous immunoglobulin (IVIg) within 5 moths prior to the screening visit
• • 17. Patients who have participated or is participating in a clinical research study evaluating COVID-19 or ARDS within 30 days prior to the screening visit