Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive 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: Adipose tissue-derived Mesenchymal Stromal Cells.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis. Базовые параметры: 18 лет — 55 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
Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis: an Open-label Phase I Clinical Trial.
Обзор
In this study, we propose, for the first time, to test the safety and the potential efficacy of repeated allogenic Adipose tissue-derived Mesenchymal Stromal Cells IT injections in Primary Progressive Multiple Sclerosis patients.
Подробное описание
In this study, the investigators propose, for the first time, to test the safety and the potential efficacy of repeated allogenic Adipose tissue-derived Mesenchymal Stromal Cells (ASCs) IT injections in Primary Progressive Multiple Sclerosis (PPMS) patients. In fact, even if autologous Bone Marrow-Mesenchymal Stromal Cells (BM-MSC) and ASCs have already been infused intrathecally in multiple sclerosis, repeated injections of allogenic ASCs have never been tested in this disease. The use of allogenic cells is driven by recent publications reporting decreased suppressive properties of autologous MSC from MS patients.
The hypothesis is that 3 repeated intrathecal (IT) injections of allogenic ASCs every 3 months will be safe and can lower disease progression in PPMS patients.
Preamble of infusing ASCs in the first patient, it's necessary to constitute and characterize the ASC bank. ASC will be obtained from Allogeneic human mesenchymal stromal cells derived from adipose tissue of a living donor.
Once the bank is available, MS patients will be screened and included in Rennes university hospital to received ASC's infusions.
MS patients will be followed for one year after inclusion
Вмешательства
- Препарат Adipose tissue-derived Mesenchymal Stromal Cells
repeated allogenic ASCs IT injections
Первичные конечные точки
- Percentage of patients experiencing at least one adverse effect [Срок оценки: 48 weeks]
Вторичные конечные точки (12)
- Description of Adverse events related to experimental product [Срок оценки: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : Confirmed Disability Progression using Expanded Disability Status Scale score [Срок оценки: 3 months]
- Clinical disease evolution at Week24 and Week48 after treatment : Expanded Disability Status Scale score [Срок оценки: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : Expanded Disability Status Scale score [Срок оценки: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : no evidence progression using 9HPT test [Срок оценки: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : no evidence progression using T25-FW [Срок оценки: 48 weeks]
- Clinical disease evolution at Week24 and Week48 after treatment : MSFC mean changes [Срок оценки: 48 weeks]
- Quality of life disease evolution at Week24 and Week48 after treatment : Multiple Sclerosis International Quality Of Life (MusiQoL) questionnaire [Срок оценки: 48 weeks]
- Immunophenotyping [Срок оценки: 48 weeks]
- Detection of donor specific anti-HLA antibodies in the blood [Срок оценки: 28 weeks]
- MRI parameters : gadolinium (Gd) enhancing lesions [Срок оценки: 48 weeks]
- MRI parameters : new T2 lesions [Срок оценки: 48 weeks]
Критерии участия
Критерии включения
- Patient with Primary Progressive MS according to the criteria of Mc Donald 2017 (Thompson et al Lancet neurol, 2017)
- Age between 18 and 55 years
- EDSS score: 3 to 6 at inclusion
- Documented evidence of disability progression independent of relapse activity at any point in time over the 2 years prior to the screening visit
- Positive CSF with oligoclonal bands
- For women of childbearing potential (WOCBP), effective contraception as per the CFTG recommendations (version 1.1)
- Having signed a free, informed and written consent
- Affiliated to social security scheme
Критерии исключения
- Inflammatory activity during the past year (relapses or new T2 MRI lesions)
- Disease Modifying Drugs during the past year
- Treatment with high dose corticosteroids during the 30 days preceding the inclusion
- Contra indication to lumbar puncture/intrathecal infusion: intracranial hypertension, puncture site infections, severe thrombocytopenia (<50 G/L), anticoagulant or fibrinolytic treatment
- Participation in another therapeutic trial in the last 6 months
- Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breastfeeding women, minors, persons unable to express their 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
- Лечение
Центры проведения
Франция · 2 центра
- APHP Henri Mondor — Créteil
- CHU Rennes — Rennes
Идентификаторы
NCT: NCT06592703 · 35RC21_9806_MAESTRO-4MS