Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage

Официальное название

A Randomized Controlled Trial Evaluating the Efficacy and Safety of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage

Обзор

This study evaluates the safety and preliminary efficacy of autologous bone marrow mononuclear cell transplantation combined with rehabilitation in children with neurological sequelae caused by hypoxic-ischemic brain injury or intracranial hemorrhage. Participants in the intervention group will receive autologous bone marrow aspiration, mononuclear cell transplantation via intrathecal route, and rehabilitation, while the control group will receive rehabilitation alone. Outcomes will be compared between groups over follow-up time points.

Подробное описание

Neurological sequelae following hypoxic-ischemic brain injury and intracranial hemorrhage in children remain a major clinical challenge with limited effective treatment options. Rehabilitation is the current standard of care but often results in incomplete recovery. Autologous bone marrow mononuclear cell transplantation has emerged as a promising therapeutic approach due to its potential neuroregenerative and neuroprotective effects. This phase II study aims to evaluate the safety and preliminary efficacy of combining autologous bone marrow mononuclear cell transplantation with rehabilitation compared to rehabilitation alone. The study will also contribute to the development of a standardized technical protocol for this intervention.

Вмешательства

• Процедура Autologous Bone Marrow Mononuclear Cell Transplantation
  Autologous bone marrow mononuclear cells (BMMNCs) are collected from the patient's iliac crest under sterile conditions. Bone marrow aspiration is performed under appropriate anesthesia, followed by processing to isolate mononuclear cells using density gradient centrifugation. The prepared BMMNCs are administered via intrathecal injection under aseptic conditions. The dosage of cells is determined based on body weight and viability criteria. Patients are monitored for immediate and delayed adve

Первичные конечные точки

• Change in Gross Motor Function Measure (GMFM-88) total score from baseline to 12 months [Срок оценки: Baseline and 12 months]

Вторичные конечные точки (4)

• Change in GMFM score at 3, 6, 9 months [Срок оценки: Baseline and 3, 6, 9 months]
• Change in Gross Motor Function Classification System (GMFCS) level from baseline to 12 months [Срок оценки: Baseline and 12 months]
• Change in Manual Ability Classification System (MACS or Mini-MACS) level from baseline to 12 months [Срок оценки: Baseline and 12 months]
• Incidence of transplantation-related adverse events [Срок оценки: From intervention through 12 months follow-up]

Критерии участия

Критерии включения

• Children diagnosed with cerebral palsy
• Age from 12 months to 72 months
• Cerebral palsy caused by hypoxic-ischemic brain injury or intracranial hemorrhage
• Gross Motor Function Classification System (GMFCS) level III to V
• Completed required laboratory tests according to the study protocol
• Written informed consent obtained from the child's parent or legal guardian

Критерии исключения

• Children with acute infection at the time of screening or enrollment
• Children with severe coagulopathy or contraindications to bone marrow aspiration
• Children with severe systemic diseases (e.g., severe cardiac, hepatic, or renal failure)
• Children with contraindications to anesthesia or intrathecal transplantation procedures
• Children with a history of malignancy
• Children who are unable to participate in or complete the rehabilitation program
• Parents or legal guardians who do not provide informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Vietnam National Children's Hospital — Hanoi

Идентификаторы

NCT: NCT07527104 · 16/HĐ-K2ĐT · 16/HĐ-K2ĐT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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