Last update 21 Nov 2024

Autologous thyTreg(Hospital General Universitario Gregorio Marañón)

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Tregs cell therapy

Synonyms

Autologous thyTreg, Thymic Tissue Derived Autologous Regulatory T Cell Therapy(Hospital General Universitario Gregorio Maranon), Treg Cells(Hospital General Universitario Gregorio Marañón)

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Immune System Diseases

Active Indication

Cardiac transplant rejection

Inactive Indication-

Originator Organization

Hospital General Universitario Gregorio Marañón

Active Organization

IISGMHospital General Universitario Gregorio Marañón

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

Clinical Trials associated with Autologous thyTreg(Hospital General Universitario Gregorio Marañón)

NCT06052436 / RecruitingPhase 1/2IIT

Open Phase I/IIa Clinical Trial to Evaluate the Safety and Efficacy of Allogenic Administration of Treg Cells Obtained From Thymic Tissue (thyTreg) to Control The Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome

The investigators developed a GMP protocol to isolate Treg cells from thymic tissue (thyTreg). The thyTreg cells are being evaluated in a Phase I/II clinical trial to evaluate the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children (NCT04924491), with preliminary results indicating the feasibility and safety of the therapy.
In addition, thyTreg cells have shown low immunogenicity in the pre-clinical setting, indicating that allogeneic use of these thyTreg cells (allo-thyTreg) would have a low risk of adverse effects. These thyTreg cells could inhibit an excessive inflammation in SARS-CoV-2 infection, or ameliorate the immunological affection underlying Acute respiratory distress syndrome, improving life-threatening manifestations, restoring immune balance, and protecting affected tissues.
This clinical trial is an open-label Sequential Parallel Group Phase I/II study to evaluate the safety and efficacy of allogeneic thymus derived Tregs (thyTreg) (thyTreg) in controlling the immune dysregulation associated with SARS-CoV-2 infection and/or Acute Respiratory Distress Syndrome.

Start Date27 Jun 2023

Sponsor / Collaborator

Hospital General Universitario Gregorio Marañón

NCT04924491 / RecruitingPhase 1/2IIT

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

Start Date10 Sep 2020

Sponsor / Collaborator

Hospital General Universitario Gregorio Marañón

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100 Clinical Results associated with Autologous thyTreg(Hospital General Universitario Gregorio Marañón)

100 Translational Medicine associated with Autologous thyTreg(Hospital General Universitario Gregorio Marañón)

100 Patents (Medical) associated with Autologous thyTreg(Hospital General Universitario Gregorio Marañón)

Literatures (Medical) associated with Autologous thyTreg(Hospital General Universitario Gregorio Marañón)

04 Dec 2023·The Journal of experimental medicine

First-in-human therapy with Treg produced from thymic tissue (thyTreg) in a heart transplant infant.

Article

Author: Hernández-Flórez, Diana ; Gil, Nuria ; Bernaldo-de-Quirós, Esther ; Dijke, I Esmé ; Fernández-Santos, Maria Eugenia ; West, Lori J ; Martínez-Bonet, Marta ; Camino, Manuela ; Levings, Megan K ; Gil-Jaurena, Juan Miguel ; Correa-Rocha, Rafael ; Butragueño, Laura ; Pion, Marjorie

Due to their suppressive capacity, regulatory T cells (Tregs) have attracted growing interest as an adoptive cellular therapy for the prevention of allograft rejection, but limited Treg recovery and lower quality of adult-derived Tregs could represent an obstacle to success. To address this challenge, we developed a new approach that provides large quantities of Tregs with high purity and excellent features, sourced from thymic tissue routinely removed during pediatric cardiac surgeries (thyTregs). We report on a 2-year follow-up of the first patient treated worldwide with thyTregs, included in a phase I/II clinical trial evaluating the administration of autologous thyTreg in infants undergoing heart transplantation. In addition to observing no adverse effects that could be attributed to thyTreg administration, we report that the Treg frequency in the periphery was preserved during the 2-year follow-up period. These initial results are consistent with the trial objective, which is to confirm safety of the autologous thyTreg administration and its capacity to restore the Treg pool.

Frontiers in Pediatrics

A New Generation of Cell Therapies Employing Regulatory T Cells (Treg) to Induce Immune Tolerance in Pediatric Transplantation

Review

Author: Bernaldo-de-Quirós, Esther ; Martínez-Bonet, Marta ; Correa-Rocha, Rafael ; Pion, Marjorie

Kidney transplantation is the most common solid organ transplant and the preferred treatment for pediatric patients with end-stage renal disease, but it is still not a definitive solution due to immune graft rejection. Regulatory T cells (Treg) and their control over effector T cells is a crucial and intrinsic tolerance mechanism in limiting excessive immune responses. In the case of transplants, Treg are important for the survival of the transplanted organ, and their dysregulation could increase the risk of rejection in transplanted children. Chronic immunosuppression to prevent rejection, for which Treg are especially sensitive, have a detrimental effect on Treg counts, decreasing the Treg/T-effector balance. Cell therapy with Treg cells is a promising approach to restore this imbalance, promoting tolerance and thus increasing graft survival. However, the strategies used to date that employ peripheral blood as a Treg source have shown limited efficacy. Moreover, it is not possible to use this approach in pediatric patients due to the limited volume of blood that can be extracted from children. Here, we outline our innovative strategy that employs the thymus removed during pediatric cardiac surgeries as a source of therapeutic Treg that could make this therapy accessible to transplanted children. The advantageous properties and the massive amount of Treg cells obtained from pediatric thymic tissue (thyTreg) opens a new possibility for Treg therapies to prevent rejection in pediatric kidney transplants. We are recruiting patients in a clinical trial to prevent rejection in heart-transplanted children through the infusion of autologous thyTreg cells (NCT04924491). If its efficacy is confirmed, thyTreg therapy may establish a new paradigm in preventing organ rejection in pediatric transplants, and their allogeneic use would extend its application to other solid organ transplantation.

Frontiers in Immunology

A Novel GMP Protocol to Produce High-Quality Treg Cells From the Pediatric Thymic Tissue to Be Employed as Cellular Therapy

Article

Author: Martínez-Bonet, Marta ; Cózar, Beatriz ; Fernández-Santos, María Eugenia ; Suarez, Susana ; Pion, Marjorie ; Pardo, Carlos ; López-Esteban, Rocío ; Camino, Manuela ; Correa-Rocha, Rafael ; Pérez-Caballero, Ramón ; Bernaldo-de-Quirós, Esther ; Pita, Ana ; Gil-Jaurena, Juan Miguel ; Clemente, Maribel ; Gil, Nuria

Due to their suppressive capacity, the adoptive transfer of regulatory T cells (Treg) has acquired a growing interest in controlling exacerbated inflammatory responses. Limited Treg recovery and reduced quality remain the main obstacles in most current protocols where differentiated Treg are obtained from adult peripheral blood. An alternate Treg source is umbilical cord blood, a promising source of Treg cells due to the higher frequency of naïve Treg and lower frequency of memory T cells present in the fetus’ blood. However, the Treg number isolated from cord blood remains limiting. Human thymuses routinely discarded during pediatric cardiac surgeries to access the retrosternal operative field has been recently proposed as a novel source of Treg for cellular therapy. This strategy overcomes the main limitations of current Treg sources, allowing the obtention of very high numbers of undifferentiated Treg. We have developed a novel good manufacturing practice (GMP) protocol to obtain large Treg amounts, with very high purity and suppressive capacity, from the pediatric thymus (named hereafter thyTreg). The total amount of thyTreg obtained at the end of the procedure, after a short-term culture of 7 days, reach an average of 1,757 x106 (range 50 x 106 – 13,649 x 106) cells from a single thymus. The thyTreg product obtained with our protocol shows very high viability (mean 93.25%; range 83.35% – 97.97%), very high purity (mean 92.89%; range 70.10% – 98.41% of CD25+FOXP3+ cells), stability under proinflammatory conditions and a very high suppressive capacity (inhibiting in more than 75% the proliferation of activated CD4+ and CD8+ T cells in vitro at a thyTreg:responder cells ratio of 1:1). Our thyTreg product has been approved by the Spanish Drug Agency (AEMPS) to be administered as cell therapy. We are recruiting patients in the first-in-human phase I/II clinical trial worldwide that evaluates the safety, feasibility, and efficacy of autologous thyTreg administration in children undergoing heart transplantation (NCT04924491). The high quality and amount of thyTreg and the differential features of the final product obtained with our protocol allow preparing hundreds of doses from a single thymus with improved therapeutic properties, which can be cryopreserved and could open the possibility of an “off-the-shelf” allogeneic use in another individual.

100 Deals associated with Autologous thyTreg(Hospital General Universitario Gregorio Marañón)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cardiac transplant rejection	Phase 2	ES	Hospital General Universitario Gregorio Marañón	10 Sep 2020

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Autologous thyTreg(Hospital General Universitario Gregorio Marañón)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation