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Идёт набор NCT06551649

Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation

Без фазы С лечением Amyotrophic Lateral Sclerosis Multiple Sclerosis

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: Venous blood draw and skin biopsy.
Кому может быть актуально
Состояния в реестре: Amyotrophic Lateral Sclerosis, Multiple Sclerosis. Базовые параметры: 20 лет — 60 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
Италия
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

Contrasting Chronic Inflammation and Neurodegeneration Using the Human Amniotic Mesenchymal Cell Secretome as an Innovative Therapeutic Strategy

Обзор

Neurodegenerative diseases are debilitating conditions characterized by chronic inflammation, leading to dysfunction of both the non-neuronal cellular components of the central nervous system and peripheral blood immune cells. Thus, it is crucial to develop an innovative therapeutic strategy that not only effectively contrast neurodegeneration but also aims to reduce inflammation. The overall aim of the study is to provide a preclinical in vitro demonstration of the immunomodulatory and pro-regenerative potential of the human amniotic mesenchymal stromal cell (hAMSC) secretome in counteracting neurodegeneration. This potential will be evaluated in three-dimensional in vitro models of neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS) and chronic demyelinating disease (multiple sclerosis - MS). To this end, the study includes sample collection from patients without pharmacological treatment and without medical devices. Patients diagnosed with ALS, patients diagnosed with MS, and healthy volunteers will be recruited to collect blood samples and skin biopsies. Patient-specific and control organoid platforms, mimicking cellular heterogeneity and tridimensional interactions within the central nervous system including the inflammatory compartment, will be developed to be used as a valuable tool to investigate the in vitro efficacy of the hAMSC secretome.

Вмешательства

  • Другое Venous blood draw and skin biopsy
    The skin tissue will be used to isolate fibroblasts, which will then be reprogrammed into induced pluripotent stem cells (iPSCs). These iPSCs will be differentiated to develop patient-specific and control organoids. The blood samples will be used to isolate peripheral blood mononuclear cells (PBMC) to study the contribution of inflammation in the in vitro models developed.

Первичные конечные точки

  • Neurite length measurement in a three-dimensional cellular model of amyotrophic lateral sclerosis. [Срок оценки: 18 months]
  • Percentage of apoptotic cells in a three-dimensional cellular model of amyotrophic lateral sclerosis. [Срок оценки: 18 months]
  • Area measurement of damaged myelin in a three-dimensional cellular model of multiple sclerosis. [Срок оценки: 18 months]
  • Number of inflamed microglial cells in a three-dimensional cellular model of multiple sclerosis. [Срок оценки: 18 months]
  • Neurite length measurement in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome. [Срок оценки: 24 months]
  • Percentage of apoptotic cells in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome. [Срок оценки: 24 months]
  • Area measurement of damaged myelin in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome. [Срок оценки: 24 months]
  • Number of immunoregulatory microglial cells in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome. [Срок оценки: 24 months]
Вторичные конечные точки (1)
  • Percentage of altered immune phenotypic markers in amyotrophic lateral sclerosis and multiple sclerosis patients [Срок оценки: 18 months]

Критерии участия

Критерии включения

  • For patients with amyotrophic lateral sclerosis (ALS): aged between 50 and 60 years and similar age of onset and duration of the disease.
  • For patients with multiple sclerosis (MS): with recently confirmed diagnosis of MS, aged between 20 and 50 years and considering the male-to-female ratio in MS of approximately 2:1.
  • For healthy volunteers: spouses of patients unaffected by any neurological disease and matching their age and gender ratio for both conditions.

Критерии исключения

  • Patients who do not consent to participate in the study.
  • MS patients who have received treatment with immunomodulators or corticosteroids and are in an acute phase of the disease.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Италия · 2 центра
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome

Идентификаторы

NCT: NCT06551649 · 6823

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗