Can donated immune cells calm the cytokine storm?
NCT ID NCT06052436
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing whether regulatory T cells taken from donated thymus tissue can control the dangerous immune overreaction that occurs in severe COVID-19 and acute respiratory distress syndrome (ARDS). The trial enrolls adults aged 18 to 65 who are hospitalized with acute respiratory failure and signs of immune hyperactivation. Participants receive one of two doses of these cells through an intravenous infusion, and researchers track infusion-related side effects and changes in intensive care outcomes such as oxygen levels and organ function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allogeneic regulatory T cells derived from donated thymus tissue (thyTreg)
- What this could lead to
- If it works, this approach could offer a way to calm runaway inflammation in severe COVID-19 and ARDS, and possibly other conditions driven by an overactive immune response.
- What could go wrong
- This is an early-stage trial with only 24 participants, so safety and any benefit are far from proven. Donated cells could trigger immune reactions, fail to help, or work differently in larger, more varied groups of patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital General Universitario Gregorio Marañon
RECRUITINGMadrid, Madrid, 28007, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Steroid dose showdown: can more dexamethasone save lives in respiratory failure?
- Breathing machine settings put to the test in severe lung injury
- The hidden breath: how a mismatch between patient and machine may shape ARDS recovery
- Scientists hunt for hidden subgroups in sudden respiratory failure
- AI plus ultrasound could catch heart and lung decline before it turns critical
- Can adjusting breathing effort during ventilation improve lung function in ARDS?