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Идёт набор NCT06788470

Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants

Фаза I / Фаза II С лечением BPD - Bronchopulmonary Dysplasia

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: MSC.
Кому может быть актуально
Состояния в реестре: BPD - Bronchopulmonary Dysplasia. Базовые параметры: от 36 Weeks · 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
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Официальное название

Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of Bronchopulmonary Dysplasia in Premature Infants

Обзор

Bronchopulmonary dysplasia (BPD) is a chronic lung disease, which is a major complication of very low and ultra-low preterm infants. Moderate and severe BPD survivors are prone to adverse outcomes such as impaired lung function, childhood exercise intolerance, and neurodevelopmental retardation in the long term, which seriously affects their quality of life and brings a heavy burden to society and families. However, the pathogenesis of BPD is complex, including pulmonary vascular dysplasia, lung inflammation, and impaired alveolar development. There is currently no specific clinical drug to cure BPD. Mesenchymal stem cells (MSCs) are a kind of multipotent stem cells that exist in almost all organs and tissues of individuals. MSCs have the properties including self-renewal, multi-directional differentiation, and immunosuppressive and anti-inflammatory abilities. Preclinical studies have shown that MSCs can alleviate BPD by improving alveolar and pulmonary vascular development, and reducing pulmonary fibrosis. Several phase I clinical studies have demonstrated that intratracheal transplantation of human umbilical cord blood-derived mesenchymal stem cells for children with BPD is safe and feasible. This study aims to further evaluate the safety and efficacy of umbilical cord-derived mesenchymal stem cell transplantation in the treatment of severe BPD in premature infants, in the hope of increasing the survival rate and improving the prognosis of severe BPD.

Вмешательства

  • Препарат MSC
    Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs).

Первичные конечные точки

  • Extubating time after MSC transplantation [Срок оценки: until 24 months of corrected age]
  • The number of times and total duration of re-intubation after extubating [Срок оценки: until 24 months of corrected age]
  • Mortality of BPD [Срок оценки: until 24 months of corrected age]
Вторичные конечные точки (3)
  • Further assess the severity of BPD by detecting the levels of pro-inflammatory cytokine in alveolar lavage fluid, pulmonary function index and chest radiography. [Срок оценки: until 24 months of corrected age]
  • Short-term safety assessment of MSC transplantation by whether anaphylaxis and severe infection are observed within 24 hours after MSC transplantation. [Срок оценки: within 24 hours after MSC transplantation]
  • long-term safety assessment of MSC transplantation by whether intraventricular hemorrhage, periventricular leukomalacia, neurodevelopmental problems and tumor formation are observed after MSC transplantation until 24 months of corrected age. [Срок оценки: until 24 months of corrected age]

Критерии участия

Критерии включения

  • 23-29 weeks of gestation, birth weight 500-1500g;
  • For patients with no improvement or aggravation of lung condition after DART hormone therapy, and positive pressure ventilation by tracheal intubation is still required at a correct gestational age of 36 weeks.
  • Children with severe BPD after early use of PS
  • Parents agree to participate in clinical trials.

Критерии исключения

  • Premature infants not suitable for the given gestational age;
  • Other congenital structural malformations of trachea, bronchus and lungs;
  • Complicated with severe congenital heart disease;
  • Complicated with Periventricular Leukomalacia (PVL);
  • Complicated with intraventricular hemorrhage (IVH) above level 3;
  • Septic shock or positive blood culture;
  • Acute pulmonary hemorrhage;
  • Intracranial and extracranial diseases affecting respiratory rate and rhythm.

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
  • The Children's Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06788470 · 2019-SC-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗