Heart TransplantationPhase 1/2THYTECHNCT04924491
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
A Phase 1/2 study testing Autologous thyTreg in people with Heart Transplantation, run by Rafael Correa-Rocha at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Autologous thyTreg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 10 Sep 2020to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.
- Patients without contraindication to immunosuppressive drugs.
- Parents and/or guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document
Who cannot join
- Patients with DiGeorge Syndrome, since their thymic function is affected.
- Human immunodeficiency virus positive serology
- Epstein-Barr virus active infection
- Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies
- Patients with a history of previous malignancy
- Patients who have participated in other intervention studies in the last month.
Show all 10Show fewer
- Patients who have received induction therapy with Basiliximab or Thymoglobulin.
- Patients who have previously been thymectomized or transplanted.
- Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
- Patients who will receive an asystole heart
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007
Rafael Correa-Rocha, PhD, rafael.correa@iisgm.com
Esther Bernaldo-de-Quiros, MsC
About this study
Official title: Randomized, Exploratory and Prospective Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of the Transfusion of Autologous Treg Cells Obtained From Thymic Tissue in the Prevention of Rejection in Heart Transplant Children
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
Read the detailed description
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.
- Conditions
- Heart Transplantation
- Being tested
- Autologous thyTreg
- Keywords
- Cardiac Disease, Regulatory T cell, Immunomodulation, Tolerogenic protocol, Immunosuppressive Agents, Immunologic Factors
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous thyTregBiological
Also called thyTreg cells
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
| Study group | Role | What they receive |
|---|---|---|
| 10.000.000 thyTreg /kg | Experimental | Autologous thyTreg 10.000.000 Receives: Biological: Autologous thyTreg |
| 20.000.000 thyTreg /kg | Experimental | Autologous thyTreg 20.000.000 Receives: Biological: Autologous thyTreg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (8)
Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography) that require treatment in the 2 years post-transplant
Measured: 24 months
Number of Treg cells in peripheral blood
Measured: 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).
Measured: 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.
Measured: 24 months
Overall patient survival rate at 24 months.
Measured: 24 months
Change on parameters of electrocardiogram (PR, QRS and corrected QT interval) of transplanted heart.
Measured: 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.
Measured: 24 months
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V4.03 criteria.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start10 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rafael Correa-Rocha
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Rafael Correa-Rocha, Hospital General Universitario Gregorio Marañon
- Investigators
- Rafael Correa-Rocha, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924491
- Sponsor's protocol ID
- THYTECH1-2018-005
- Other IDs
- 2024-519845-30, 2018-003574-28, 2018
- Acronym
- THYTECH
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernaldo-de-Quiros E, Cozar B, Lopez-Esteban R, Clemente M, Gil-Jaurena JM, Pardo C, Pita A, Perez-Caballero R, Camino M, Gil N, Fernandez-Santos ME, Suarez S, Pion M, Martinez-Bonet M, Correa-Rocha R. A Novel GMP Protocol to Produce High-Quality Treg Cells From the Pediatric Thymic Tissue to Be Employed as Cellular Therapy. Front Immunol. 2022 May 16;13:893576. doi: 10.3389/fimmu.2022.893576. eCollection 2022.
PubMed 35651624
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Exploratory and Prospective Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of the Transfusion of Autologous Treg Cells Obtained From Thymic Tissue in the Prevention of Rejection in Heart Transplant Children
- ClinicalTrials.gov ID
- NCT04924491
- Acronym / sponsor ID
- THYTECH / THYTECH1-2018-005
- Conditions
- Heart Transplantation
- Keywords
- Cardiac Disease, Regulatory T cell, Immunomodulation, Tolerogenic protocol, Immunosuppressive Agents, Immunologic Factors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Rafael Correa-RochaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10.000.000 thyTreg /kg | Experimental | Biological: Autologous thyTregAutologous thyTreg 10.000.000 |
| 20.000.000 thyTreg /kg | Experimental | Biological: Autologous thyTregAutologous thyTreg 20.000.000 |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.
- Patients without contraindication to immunosuppressive drugs.
- Parents and/or guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document
Key exclusion criteria (10 listed)
- Patients with DiGeorge Syndrome, since their thymic function is affected.
- Human immunodeficiency virus positive serology
- Epstein-Barr virus active infection
- Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies
- Patients with a history of previous malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous thyTregAlso: thyTreg cellsTreg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg) | Biological | 10.000.000 thyTreg /kg, 20.000.000 thyTreg /kg |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Derived from this study: PubMed 35651624Bernaldo-de-Quiros E, Cozar B, Lopez-Esteban R, Clemente M, Gil-Jaurena JM, Pardo C, Pita A, Perez-Caballero R, Camino M, Gil N, Fernandez-Santos ME, Suarez S, Pion M, Martinez-Bonet M, Correa-Rocha R. A Novel GMP Protocol to Produce High-Quality Treg Cells From the Pediatric Thymic Tissue to Be Employed as Cellular Therapy. Front Immunol. 2022 May 16;13:893576. doi: 10.3389/fimmu.2022.893576. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Heart Transplantation
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Enrolling by invitationObservational study
Donor Derived Cell Free DNA (Dd-cfDNA) as a Biomarker for Allograft Rejection in Heart Transplant Recipients
Heart Transplantation
RecruitingObservational study
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Heart Failure, Liver Fibrosis
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael Correa-Rocha, PhD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous thyTreg in people with Heart Transplantation, run by Rafael Correa-Rocha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael Correa-Rocha, PhD (34 915866455, rafael.correa@iisgm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.