Status:
RECRUITING
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)
Lead Sponsor:
Hospital General Universitario Gregorio Marañon
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Systemic Inflammatory Response Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The investigators developed a GMP protocol to isolate Treg cells from thymic tissue (thyTreg). The thyTreg cells are being evaluated in a Phase I/II clinical trial to evaluate the safety and efficacy ...
Detailed Description
The immune system is the body's defense system against pathogens and other harmful agents, but it is also responsible for transplant rejection or autoimmune diseases. Another scenario of disproportion...
Eligibility Criteria
Inclusion
- Patient over 18 to 65 years of age
- Patient Informed and non-opposed to the research by his medical doctor during hospitalization
- Patient with clinical, radiological, gasometric and immunological criteria defined as:
- Acute respiratory failure secondary to acute lung injury of noncardiogenic cause
- Pulmonary abnormalities compatible with bilateral alveoloinsterstitial infiltrates by chest imaging (radiograph or scan)
- 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
- Pregnancy or breast feeding
- Body mass index \>35
- Patients not expected to survive 48 hours after enrolment based on clinical assessment
- Patients with an extracorporeal respiratory support
- Neutropenia (absolute neutrophil count \<1000/uL)
- Thrombocytopenia (absolute neutrophil count \<50000/uL)
- Positive serology for HBV, HCV, or HIV at Screening
- Life expectancy of less than 6 months due to other pathologies
- History of significant underlying pulmonary disease requiring oxygen therapy prior to inclusion.
- Patients with a history of autoimmune diseases
- Patients with a history of hematopoietic neoplasia or oncology disease
- Patients with a history of hematopoietic or solid organ transplant
- Patients with a congenital or induced immunodeficiency
- Patients received thymoglobulin, basiliximab or any anti-T-cell therapies within 6 moths prior to the screening visit
- Patients received other cell therapy in the last 12 months
- Patients received intravenous immunoglobulin (IVIg) within 5 moths prior to the screening visit
- 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
Key Trial Info
Start Date :
June 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06052436
Start Date
June 27 2023
End Date
December 31 2027
Last Update
February 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28007