Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
NCT ID: NCT04924491
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
11 participants
INTERVENTIONAL
2020-09-10
2026-12-31
Brief Summary
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Condition or disease: Heart Transplantation Intervention/treatment: Regulatory T Cell (Treg) Infusion
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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10.000.000 thyTreg /kg
Autologous thyTreg 10.000.000
Autologous thyTreg
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
20.000.000 thyTreg /kg
Autologous thyTreg 20.000.000
Autologous thyTreg
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
Interventions
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Autologous thyTreg
Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
2 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Rafael Correa-Rocha
OTHER
Responsible Party
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Rafael Correa-Rocha
Group Leader
Principal Investigators
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Rafael Correa-Rocha, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañon
Locations
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Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2024-519845-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2018-003574-28
Identifier Type: OTHER
Identifier Source: secondary_id
THYTECH1-2018-005
Identifier Type: -
Identifier Source: org_study_id
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