A Phase 1/2 interventional study of Autologous thyTreg in Heart Transplantation, sponsored by Rafael Correa-Rocha. Recruiting at 1 site in Spain. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Rafael Correa-Rocha · Phase 1/2, Interventional, and Prevention
Among 79 studies in Heart Diseases with a site in Spain — 23 open to participants now, 31 under way, 3 of them phase 3. Heart Diseases · Spain.
Among the 79 studies in Heart Diseases with a site in Spain, this one is the 54th largest by planned enrollment of the 55 interventional ones that give a count, is one of 5 that started in 2020, is the only one in phase 1/2, reaches primary completion later than 8 of the 30 other live ones, and was the 51st registered.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's planned enrollment of 11 is below the median of 129 across 931 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →23 of the 79 studies in Heart Diseases with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 180 Heart Diseases studies recruiting now, 128 (71%) set no upper age limit and 21 (12%) stop at 75 or younger; 32 take children under 18; 42 take healthy volunteers.
This study: Up to 2 Years · all sexes · no healthy volunteers.
The full table on the hub →79 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 5 started in 2020.
Median enrollment 300 across the 55 interventional studies, 627 across the 24 observational. Of the 43 that completed or were terminated, 16 (37%) have results posted.
51 of 79 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Rafael Correa-Rocha as lead sponsor.
Rafael Correa-Rocha has 1 study filed under Heart Diseases — fewer than ten, so there is no comparison to draw.
10 of the studies in Heart Diseases with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06799780IRCCS Azienda Ospedaliero-Universitaria di BolognaStudy on Post-acute Myocardial Infarction Ventricular Defect: Outcome Evalutation in Relation to Surgical Timing | 2026-11-30 |
| NCT05890716Idoven 1903 S.L.AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM) | 2026-12 |
| NCT04924491Rafael Correa-RochaCell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children | 2026-12-31 |
| NCT03142152Cardiac Dimensions, Inc.The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR | 2026-12-31 |
| NCT06621524OrbusNeichEucaLimus Post-Market Registry | 2027-01 |
Among the 79 studies in Heart Diseases with a site in Spain, from their registry updates:
The investigators developed a protocol to isolate Treg cells from thymic tissue (thyTreg) discarded in pediatric cardiac surgeries. After completing the pre-clinical studies, the investigators have initiated a phase I/II clinical trial to test the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children.
Condition or disease: Heart Transplantation Intervention/treatment: Regulatory T Cell (Treg) Infusion
Current transplant practice is far from guaranteeing the life expectancy of patients, particularly if the patients are children. THYTECH aims to revolutionize the field of clinical immunology developing a new approach to govern the regulatory skills of immune system, preventing graft rejection and opening a new frontier in the treatment of immune diseases.
Transfer of regulatory T cells (Treg) has acquired growing interest in the race to achieve indefinite transplant survival. Up to now, the use of Treg therapy to prevent solid graft rejection in humans has demonstrated that this therapy is safe, but the clinical efficacy is limited. The small Treg numbers that can be purified from peripheral blood along with the low survival and limited suppressive capacity of differentiated Tregs obtained from adults have probably compromised the efficacy of this therapy.
The investigators have developed an innovative approach to overcome current barriers and make Treg transfer a reality equipped to achieve indefinite graft survival. The major innovation of THYTECH is the employment of thymic tissue, the site of Treg generation, as a new source of Tregs to obtain massive amounts of thymus-derived Tregs (thyTreg) with very high purity (>95% of CD 25+ Foxp3+ cells) and improved survival and suppressive capacities. The investigators are recruiting patients in a clinical trial transferring autologous Tregs in heart-transplanted children to prevent graft rejection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autologous thyTreg 10.000.000
Biological: Autologous thyTreg
Autologous thyTreg 20.000.000
Biological: Autologous thyTreg
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
Also known as: thyTreg cells
Repopulation of Treg cells in the patient, determined as the increase of Treg values in peripheral blood with respect to pre-transplant values or in comparison with a control cohort of non-treated patients.
Time frame: 24 months
Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography) that require treatment in the 2 years post-transplant
Time frame: 24 months
Number of Treg cells in peripheral blood
Time frame: 24 months
Change in the number of naive and memory Treg cells, and the production/levels of interferon gamma and interleukins (IL-4, IL-17A and IL-10).
Time frame: 24 months
Decrease of cell subsets related with rejection (CD8 T cells subsets, activated T cells, antibody-secreting B cells) during the post-transplant follow-up period.
Time frame: 24 months
Overall patient survival rate at 24 months.
Time frame: 24 months
Change on parameters of electrocardiogram (PR, QRS and corrected QT interval) of transplanted heart.
Time frame: 24 months
Change on parameters of echocardiogram (mitral and tricuspid regurgitation; mitral and tissue mitral Doppler; and tricuspid and tissue tricuspid Doppler ) of transplanted heart.
Time frame: 24 months
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V4.03 criteria.
Time frame: 24 months
Plan to share: No
Started Sep 2020 (actual). Primary completion is estimated for Dec 2026, 75 months after the start.
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