Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to

Status Recruiting

Clinical 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 prevent rejection in heart transplant children. Condition or disease: Heart Transplantation Intervention/treatment: Regulatory T Cell (Treg) Infusion

Clinical Trial 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

Related Conditions & MeSH terms

Heart Transplantation

Clinical Trial Details

NCT number	NCT04924491
Study type	Interventional
Source	Hospital General Universitario Gregorio Marañon
Contact	Rafael Correa-Rocha, PhD
Phone	+34 915866455
Email	rafael.correa@iisgm.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	September 10, 2020
Completion date	December 31, 2026

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See also
Status	Clinical Trial	Phase
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Completed	`NCT01028599` - Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients	N/A
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Terminated	`NCT00420537` - Shift to Everolimus (RAD) Kidney Sparing Study	Phase 4
Enrolling by invitation	`NCT03292861` - The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients	Phase 2
Recruiting	`NCT05270902` - Haemoadsorption During Heart Transplantation	N/A
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Recruiting	`NCT03687723` - Observational Study of the Clinical Use of the OCS™ Heart
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Completed	`NCT01182571` - Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients	N/A
Terminated	`NCT00678002` - Quality of Life in Pediatric Transplant Patients
Withdrawn	`NCT00780637` - Brachial Artery t-PA Release in Heart Transplant Recipients	N/A
Withdrawn	`NCT00780377` - Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients	N/A
Withdrawn	`NCT00572286` - Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study	N/A
Terminated	`NCT00121784` - Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients	Phase 4
Completed	`NCT00690157` - Registry of Patients Referred for Heart Transplantation	N/A
Completed	`NCT00123331` - Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children — THYTECH

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms