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Набор скоро начнётся NCT06638970

Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Drug Resistant Epilepsy Single Center, Non-randomized, Phase I Clinical Trial

Фаза I С лечением Epilepsy Drugs Resistant Epilepsy

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: Secretome.
Кому может быть актуально
Состояния в реестре: Epilepsy, Drugs Resistant Epilepsy. Базовые параметры: 18 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
Индонезия
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 goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with epilepsy. The main questions it ams to answer are: 1. How is the relationship between secretome therapy and the reduction in seizure frequency and duration in patients with drug-resistant epilepsy in the adult age group? 2. How does secretome therapy affect EEG and qEEG results in patients with drug-resistant epilepsy in the adult age group? 3. How is the relationship between secretome therapy and the Mini Mental State Examination (MMSE) score in patients with drug-resistant epilepsy in the adult age group? 4. How does secretome therapy affect stress levels as measured by the Perceived Stress Scale (PSS) in patients with drug-resistant epilepsy in the adult age group? 5. How does secretome therapy affect Gait Deviation Index (GDI) scores in patients with drug-resistant epilepsy in the adult age group? 6. How does secretome therapy affect quality of life as measured by the Quality of Life in Epilepsy Inventory (QOLIE-31) in patients with drug-resistant epilepsy in the adult age group?

Вмешательства

  • Препарат Secretome
    3 ml Injection of secretome for 4 times two weeks apart

Первичные конечные точки

  • Changes frequency and duration of the seizures in drugs resistant epilepsy after two months secretome injections [Срок оценки: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months]
  • Changes in EEG and qEEG (Alpha,Beta, Delta, and Theta wave) results of drugs resistant epilepsy after two months secretome injections [Срок оценки: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months]
Вторичные конечные точки (3)
  • Changes in Mini Mental State Examination (MMSE) results of drugs resistant epilepsy after two months secretome injections [Срок оценки: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months]
  • Changes in Perceived Stress Scale (PSS) results of drugs resistant epilepsy after two months secretome injections [Срок оценки: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months]
  • Changes in Gait Deviation Index (GDI) results of drugs resistant epilepsy after two months secretome injections [Срок оценки: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months]

Критерии участия

Критерии включения

  • Individuals aged 18 to 60 years.
  • Individuals with a clinical diagnosis of epilepsy confirmed by a neurologist based on internationally accepted criteria.
  • Individuals with a seizure frequency of at least 6 times in 12 months.
  • Individuals who have a history of recurrent seizures that are not controlled with standard antiepileptic treatment of at least 2 types of drugs for at least 12 months.
  • Individuals who are in stable general health, without life-threatening acute illnesses or uncontrolled medical conditions.
  • Individuals who do not have a history of other neurodegenerative diseases or severe psychiatric disorders that could affect the results of the study.
  • Individuals who are not pregnant or breastfeeding.
  • Individuals who are willing to provide written consent after receiving complete information about the study.

Критерии исключения

  • Individuals with a history of stroke or evidence of stroke on medical examination.
  • Individuals who have undergone surgery for the treatment of epilepsy.
  • Individuals with a history of allergy or hypersensitivity reactions to the secretome or related components.
  • Individuals with active or uncontrolled autoimmune disease.
  • Individuals receiving immunosuppressive therapy.
  • Individuals with severe hepatic or renal impairment.
  • Individuals with significant vascular or blood vessel disease.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Индонезия · 1 центр
  • Main Clinic Prof. Dadang Hawari — Jakarta

Идентификаторы

NCT: NCT06638970 · 001-UTHREC/UNTAR/I/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗