Cell Therapy with Treg Cells Obtained from Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children (THYTECH)

January 30, 2025 updated by: Rafael Correa-Rocha

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

11

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Marta Martínez-Bonet, PhD
        • Contact:
          • Marjorie Pion, PhD
        • Contact:
          • Diana Hernández-Flórez, PhD
        • Contact:
          • Juan Miguel Gil-Jaurena, MD
        • Contact:
          • Carlos Pardo, MD PhD
        • Contact:
          • Ramón Pérez-Caballero, MD PhD
        • Contact:
          • Mª Eugenia Fernández-Santos, PhD
        • Contact:
        • Contact:
          • Esther Bernaldo-de-Quiros, MsC
        • Contact:
          • Manuela Camino Lopez, MD PhD
        • Contact:
          • Nuria Gil Villanueva, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.
  2. Patients without contraindication to immunosuppressive drugs.
  3. 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

Exclusion Criteria:

  1. Patients with DiGeorge Syndrome, since their thymic function is affected.
  2. Human immunodeficiency virus positive serology
  3. Epstein-Barr virus active infection
  4. Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies
  5. Patients with a history of previous malignancy
  6. Patients who have participated in other intervention studies in the last month.
  7. Patients who have received induction therapy with Basiliximab or Thymoglobulin.
  8. Patients who have previously been thymectomized or transplanted.
  9. Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
  10. Patients who will receive an asystole heart

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10.000.000 thyTreg /kg
Autologous thyTreg 10.000.000
Biological: Autologous thyTreg
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
Other Names:
  • thyTreg cells
Experimental: 20.000.000 thyTreg /kg
Autologous thyTreg 20.000.000
Biological: Autologous thyTreg
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
Other Names:
  • thyTreg cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography) that require treatment in the 2 years post-transplant
Time Frame: 24 months
24 months
Number of Treg cells in peripheral blood
Time Frame: 24 months
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
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
24 months
Overall patient survival rate at 24 months.
Time Frame: 24 months
24 months
Change on parameters of electrocardiogram (PR, QRS and corrected QT interval) of transplanted heart.
Time Frame: 24 months
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
24 months
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V4.03 criteria.
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rafael Correa-Rocha

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Rafael Correa-Rocha, PhD, Hospital General Universitario Gregorio Marañon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • THYTECH1-2018-005
  • 2018-003574-28 (Other Identifier: AEMPS)
  • 2024-519845-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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