2024-519845-30-00招募中1 期
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
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2025年1月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
The main objective is to evaluate the feasibility, safety and efficacy of the infusion of autologous thyTreg cells in the prevention of acute rejection in children transplanted from the heart.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient under two years of age, who meets all the requirements necessary 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.
排除标准
- •Patients with DiGeorge Syndrome, since their thymic function is affected. 2) HIV positive
- •HIV positive serology.
- •Active infection by EBV
- •Patients hyperimmunized with cytotoxic anti-HLA antibodies
- •Patients with a history of prior malignancy
- •Patients who have received induction therapy with Basiliximab or Thymoglobulin
- •Patients who have been previously timectomized or transplanted.
- •Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
- •Patiens who have to receive a heart in asystolia
结局指标
主要结局
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
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
次要结局
- 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)
研究者
Maria del Carmen de la Cruz Arguedas
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
研究点 (1)
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