Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders
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: clonal fetal MSCs.
- Кому может быть актуально
- Состояния в реестре: Immune Related Disorder, Tissue Damage. Базовые параметры: 1 год — 80 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The primary objectives are to evaluate the safety and efficacy of infusion of the third party fully-characterized clonally derived fetal MSCs (cfMSCs) for the control of severe symptoms associated with acute and chronic immune-related disorders and tissue damage.
Подробное описание
MSCs have been extensively studied and clinically evaluated for the treatment of autoimmune diseases and graft versus host disease (GVHD) after hematopoietic stem cell transplantation (HSCT). The variable source of MSCs and the lack of consistency of primary tissue-derived MSCs are major obstacles to reliable translational applications of such therapeutic cell products. Fetal tissue-derived clonal MSCs (cfMSCs) have extended expansion potential and express rich levels of various growth factors, and thus can achieve quality consistency. Careful evaluation of fMSCs in clinical studies has not been conducted. Autoimmune diseases involve aberrant immune responses that harm tissues and organs. GVHD is a serious and often fatal problem associated with HSCT. MSCs have immunomodulatory and immunosuppressive effects. In many studies, MSCs have demonstrated promising beneficial effects that reduce severe autoimmune reactions, diminish symptoms of chronic GvHD and therapy-resistant acute GvHD including steroid-resistant GVHD. The safety and therapeutic effects of phenotype and functionally characterized fMSCs still require extensive clinical evaluation. This study aims to assess the safety and the potential beneficial effects of infusion of various dosages of third party fMSCs for the control of severe symptoms associated with acute and chronic immune-related disorders.
Вмешательства
- Биопрепарат clonal fetal MSCs
clonal fetal MSCs
Первичные конечные точки
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: up to one month]
Вторичные конечные точки (1)
- Number of participants with reduced symptoms or stabilized conditions after treatment [Срок оценки: after 1 month from fMSC infusion]
Критерии участия
Критерии включения
- Informed consent.
- No available alternative treatment that can reduce the symptoms
- Patients are required to meet the following inclusion criteria:
- Any patient that has clinically documented abnormal immune or age-related disorders including acute and chronic GVHD. Patients may receive best available treatment for the control of disease symptoms.
- Patients with symptoms associated with genetic defects or infectious diseases are not eligible.
Критерии исключения
- Inability to give informed consent.
- Patients with ongoing infection or history of cancer.
- Patients with poor clinical conditions with the life expectancy of less than 14 days.
- Pregnancy.
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
- Лечение
Центры проведения
Китай · 1 центр
- Shenzhen Geno-immune Medical Institute — Шэньчжэнь
Идентификаторы
NCT: NCT03123458 · GIMI-IRB-17001