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Phase I / II clinical trial, randomized, exploratory and prospective to evaluate the safety and efficacy of the transfusion of autologous TREG cells obtained from thymic tissue in the prevention of rejection in heart transplanted children

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519845-30-00
Acronym
THYTECH1-2018-005
Enrollment
11
Registered
2025-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To evaluate the efficacy in the prevention of the rejection of the transfusion of autologous thyTreg cells in children transplanted from the heart

Brief summary

Repopulation of Treg cells in the patient, determined as the increase of their blood values and the recovery of the ratio Treg / T-effector cells with respect to the values prior to transplantation

Detailed description

Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography and / or biopsy) that requires treatment in the 2 years post-transplant, Restoration of immunological homeostasis in terms of values of immune populations. The percentages and absolute values of T, B, NK and Treg lymphoid populations and of monocytes, dendritic cells and granulocytes during the post-transplant follow-up period (+7, +14, +21, +30, +60, +90, +120, +150, +180, +270, +365, +545, +730 days), Survival of the patient, Security (according to criteria NCI-CTCAE V4.03)

Interventions

DRUGCélulas linfocíticas Treg
DRUGdiferenciadas
DRUGautólogas
DRUGde tejido tímico
DRUGexpandidas y estimuladas con IL-2 (thyTreg)

Sponsors

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Repopulation of Treg cells in the patient, determined as the increase of their blood values and the recovery of the ratio Treg / T-effector cells with respect to the values prior to transplantation—

Secondary

MeasureTime frame
Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography and / or biopsy) that requires treatment in the 2 years post-transplant, Restoration of immunological homeostasis in terms of values of immune populations. The percentages and absolute values of T, B, NK and Treg lymphoid populations and of monocytes, dendritic cells and granulocytes during the post-transplant follow-up period (+7, +14, +21, +30, +60, +90, +120, +150, +180, +270, +365, +545, +730 days), Survival of the patient, Security (according to criteria NCI-CTCAE V4.03)—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026