Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
THYTECH
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
3 other identifiers
interventional
11
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2020
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2020
CompletedFirst Submitted
Initial submission to the registry
April 30, 2021
CompletedFirst Posted
Study publicly available on registry
June 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 3, 2025
October 1, 2024
6.3 years
April 30, 2021
January 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
24 months
Secondary Outcomes (8)
Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography) that require treatment in the 2 years post-transplant
24 months
Number of Treg cells in peripheral blood
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).
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.
24 months
Overall patient survival rate at 24 months.
24 months
- +3 more secondary outcomes
Study Arms (2)
10.000.000 thyTreg /kg
EXPERIMENTALAutologous thyTreg 10.000.000
20.000.000 thyTreg /kg
EXPERIMENTALAutologous thyTreg 20.000.000
Interventions
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rafael Correa-Rochalead
- Instituto de Salud Carlos IIIcollaborator
Study Sites (1)
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007, Spain
Related Publications (1)
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.
PMID: 35651624DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Correa-Rocha, PhD
Hospital General Universitario Gregorio Marañon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Group Leader
Study Record Dates
First Submitted
April 30, 2021
First Posted
June 14, 2021
Study Start
September 10, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 3, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share