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 of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children (NCT04924491), with preliminary results indicating the feasibility and safety of the therapy.
In addition, thyTreg cells have shown low immunogenicity in the pre-clinical setting, indicating that allogeneic use of these thyTreg cells (allo-thyTreg) would have a low risk of adverse effects. These thyTreg cells could inhibit an excessive inflammation in SARS-CoV-2 infection, or ameliorate the immunological affection underlying Acute respiratory distress syndrome, improving life-threatening manifestations, restoring immune balance, and protecting affected tissues.
This clinical trial is an open-label Sequential Parallel Group Phase I/II study to evaluate the safety and efficacy of allogeneic thymus derived Tregs (thyTreg) (thyTreg) in controlling the immune dysregulation associated with SARS-CoV-2 infection and/or Acute Respiratory Distress Syndrome.
Patient over 18 to 65 years of age
Patient Informed and non-opposed to the research by his medical doctor during hospitalization
Acute respiratory failure secondary to acute lung injury of noncardiogenic cause
Pulmonary abnormalities compatible with bilateral alveoloinsterstitial infiltrates by chest imaging (radiograph or scan)
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
Factorial
Allogeneic thyTreg 5.000.000
Biological/VaccineTreg lymphocytic cells, differentiated, allogeneic, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
Allogeneic thyTreg 10.000.000
Biological/VaccineTreg lymphocytic cells, differentiated, allogeneic, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
1. Incidence of infusion-related adverse events (safety) by type, frequency, severity, and causality
Length of intensive care unit stay
Oxygenation improvement as assessed using PaO2/FiO2 and/or SaO2/FiO2
Change in clinical status as assessed using Sequential Organ Failure Assessment Score
Change in clinical status as assessed using Acute Physiology and Chronic Health disease Classification System (APACHE) III
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Hospital General Universitario Gregorio Marañon
Lead sponsor
Instituto de Salud Carlos III
Collaborator
