Actively 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)
Led by Hospital General Universitario Gregorio Marañon · Updated on 2025-02-03
24
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
Sponsors
H
Hospital General Universitario Gregorio Marañon
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 to 65 years of age
- Patient informed and not opposed to the research by their 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)
- 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
You will not qualify if you...
- Pregnancy or breastfeeding
- Body mass index >35
- Patients not expected to survive 48 hours after enrolment based on clinical assessment
- Patients with 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
- History of autoimmune diseases
- History of hematopoietic neoplasia or oncology disease
- History of hematopoietic or solid organ transplant
- Congenital or induced immunodeficiency
- Received thymoglobulin, basiliximab or any anti-T-cell therapies within 6 months prior to the screening visit
- Received other cell therapy in the last 12 months
- Received intravenous immunoglobulin (IVIg) within 5 months prior to the screening visit
- Participated or is participating in a clinical research study evaluating COVID-19 or ARDS within 30 days prior to the screening visit
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28007
Actively Recruiting
Research Team
M
Marta Martínez-Bonet, PhD
CONTACT
D
Diana Hernández Flórez, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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