Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Extracorporeal phototherapy.
- Кому может быть актуально
- Состояния в реестре: Kidney Transplantation. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation: IPECAM
Обзор
Chronic AntiBody-Mediated Rejection (cABMR) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring. Extracorporeal phototherapy (ECP) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to UltraViolet A (UVA) and re-injecting them to the patient. This treatment is used as common care in the first line as part of the treatment of cutaneous T lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft. The mechanisms underlying the action of the ECP are not well known. They are mediated by the reinjection of cells exposed to UVA which enter apoptosis and induce immunomodulation. Recent work during cABMR shows that TFH lymphocytes, the maturing population of B lymphocytes, are deregulated and activated. The hypothesis is that ECP can modulate T Follicular Helper (TFH) lymphocytes during cABMR.
Вмешательства
- Другое Extracorporeal phototherapy
The principle of ECP is to collect mononucleated cells from the blood by centrifugation. After purification, the mononucleated cells are incubated ex-vivo with a photo-activatable DNA intercalating agent (8-methoxypsoralen, UVADEX®), then re-injected to the patient.
Первичные конечные точки
- Frequency of TFH cells and their activation markers [Срок оценки: From the 1st session of ECP to 1 year after the 1st session]
Вторичные конечные точки (6)
- Subsequent ECP response in patients with cABMR [Срок оценки: 3 months of treatment per ECP]
- Concentration of pro and anti-inflammatory cytokines [Срок оценки: From the 1st session of ECP to 1 year after the 1st session]
- Concentration of circulating B-cell populations [Срок оценки: From the 1st session of ECP to 1 year after the 1st session]
- Measurement of genetic markers in TFH cells [Срок оценки: At 1 week of the 1st session of ECP and at 3 month after the 1st session]
- Comparison of clinical data of patients [Срок оценки: From the 1st session of ECP to 1 year after the 1st session]
- Comparison of biological data of patients [Срок оценки: From the 1st session of ECP to 1 year after the 1st session]
Критерии участия
Критерии включения
- ECP treatment decision based on transplant team habits (care management)
- Age ≥ 18 years
- Affiliation to a French social security scheme
- Kidney transplant at least 6 months prior to inclusion
- cABMR proven by a renal graft biopsy less than 3 months and meeting the following histological criteria:
- allograft glomerulopathy (cg>0, and maximum score cg2) or intimal fibrosis
- C4d positive or ptc+g greater than or equal to 2
- Presence of Donor Specific Antibody (DSA)
- Interstitial Fibrosis and Tubular Atrophy (IFTA) less than or equal to 2
- Glomerular filtration rate > 30 mL/min/1.73 m2
- Signed informed consent to participate in the study
Критерии исключения
- Active infection or infection with hepatitis B, C or HIV virus
- Pregnant, breastfeeding or parturient woman
- Person deprived of liberty by judicial or administrative decision
- Person receiving psychiatric care under duress
- Person subject to legal protection
- Person out of state to express consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Франция · 4 центра
- Chu Besancon — Besançon
- CHU Clermont Ferrand — Clermont-Ferrand
- Chu Saint Etienne — Saint-Etienne
- CHU de STRASBOURG — Strasbourg
Идентификаторы
NCT: NCT04870437 · 2021-A00580-41