Меню
Идёт набор NCT05882110

Amplification of Autologous Epidermal Cells to Repair Large Area Deep Wounds

Без фазы С лечением Autologous Epidermal Cell Transplantation

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: Cultured autologous epidermal cell membrane.
Кому может быть актуально
Состояния в реестре: Autologous Epidermal Cell Transplantation. Базовые параметры: Без ограничений · 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Autologous epidermal cell transplantation is based on the principle and technology of skin tissue engineering, and is performed by cutting small pieces of autologous skin from patients, isolating and culturing and expanding them, and then transplanting them to the patient's wounds to repair the damage.

Подробное описание

Timely wound repair has been a great challenge in the treatment of patients with large deep burns. The current conventional approach is to use autologous skin grafts, such as micro-skin grafts, stamp skin grafts, and mesh skin grafts. Since there is very little normal skin left after large deep burns and the expansion of autologous skin grafts is limited (3-15 times), repeated skin grafting procedures are needed to repair the wound gradually, resulting in a long course of disease, scar growth and contracture, which seriously affects the quality of survival and even endangers life. Especially for patients with very large deep burns, there is an extreme shortage of normal skin sources, so they face the dilemma of having no rice to cook and unable to repair their wounds.

Based on the principle and technology of skin tissue engineering, autologous epidermal cell transplantation can provide sufficient skin source for patients with large deep burns by cutting very small pieces of autologous skin (about 2-10 cm2) and expanding them by 1000-5000 times after 2-3 weeks of in vitro culture. Autologous epidermal cell membranes combined with a large proportion of expanded autologous dermis (e.g. stamp skin, reticular skin) can significantly shorten the interstitial fusion time, improve the survival rate of autologous dermis transplants, and reduce scar growth after wound healing; autologous epidermal cell membranes combined with allogeneic dermis transplants can repair third-degree burn wounds, thus providing a large number of dermis sources for patients with lack of dermis sources, and has become an important treatment tool for saving the lives of patients with large deep burns. It has become an important treatment tool to save the lives of patients with large deep burns.

Вмешательства

  • Процедура Cultured autologous epidermal cell membrane
    The cultured autologous epidermal cell membrane is made from the patient's autologous epidermal cells by in vitro rapid expansion and culture technology, which has good biocompatibility, non-toxic, non-teratogenic, can reduce the skin area cut by traditional autologous skin grafting methods, and has high proliferative activity to promote wound repair and regeneration.

Первичные конечные точки

  • Take rate of cultured epidermal autograft [Срок оценки: 4 weeks]
  • The incidence of serious adverse events [Срок оценки: week 52 after applying CEA]

Критерии участия

Критерии включения

  • Patients with a body surface trauma of 30% TBSA or more and a wound that requires at least 2 weeks to repair as assessed by the clinician

Критерии исключения

  • Patient body surface trauma area less than 30% TBSA

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
  • Yicheng Ma — Шанхай

Идентификаторы

NCT: NCT05882110 · AOAECTRLADW

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗