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Идёт набор NCT07580755

Mesenchymal Stem Cells in the Treatment of Burn Wounds

Без фазы С лечением Burn Injury Burn Patients

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: low-dose stem cell gel group, high-dose stem cell gel group, with only the gel.
Кому может быть актуально
Состояния в реестре: Burn Injury, Burn Patients. Базовые параметры: 18 лет — 65 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
Китай
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

A Randomized Controlled Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Extensive Burns

Обзор

Burn patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), and received the same treatment under the same conditions simultaneously.

Подробное описание

This study adopted a randomized, double-blind, parallel-controlled research method. It planned to enroll 90 burn patients who underwent autologous thick skin transplantation. These patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), with 30 patients in each group. The three groups of subjects received the same treatment under the same conditions simultaneously.

Вмешательства

  • Комбинированный продукт low-dose stem cell gel group
    Using hydrogels containing low-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
  • Комбинированный продукт high-dose stem cell gel group
    Using hydrogels containing or without differenthigh-doses of placenta-derived mesenchymal stem cells as wound dressings to promote wound healing in burn patients after thick skin grafting
  • Другое with only the gel
    Using only hydrogels as wound dressings to promote wound healing in burn patients after thick skin grafting

Первичные конечные точки

  • Re-epithelialization areas [Срок оценки: Up to 6 month]
  • Complete burn wound healing [Срок оценки: Up to 12 month]

Критерии участия

Критерии включения

  • Voluntary participation and signing of the informed consent form;
  • Burn patients, subjects requiring autologous skin grafting;
  • Age 18 to 65 years old, gender not restricted;
  • During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment;
  • Skin burn area < 30% of total body surface area (TBSA);
  • The donor skin area is the first time for donation, and the donor skin area is medium-thick skin (thickness approximately 0.4mm);
  • The area of the excised skin flap ≥ 90 cm2;
  • Able to cooperate with this study protocol and accept regular postoperative follow-up visits.

Критерии исключения

  • Those allergic to sodium alginate (gel component);
  • Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
  • Subjects with severe systemic diseases (judged by the researchers);
  • Subjects with uncontrolled hypertension or diabetes (judged by the researchers);
  • Pregnant or lactating women;
  • Subjects whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the efficacy assessment;
  • Subjects with acute or chronic kidney diseases, renal failure or serum creatinine level = 1.5 times the upper limit of normal value;
  • Subjects with acute or chronic liver diseases, total bilirubin, alanine aminotransferase, aspartate aminotransferase = 2.0 times the upper limit of normal value;
  • Subjects with a history of malignant tumors;
  • Subjects who have participated in other clinical studies for less than 3 months;
  • Subjects with mental disorders and without self-awareness, unable to express clearly;
  • Subjects using immunosuppressants and those who have been using corticosteroids for a long time (more than 1 month) (excluding local application);
  • Subjects with infectious diseases (any one of the four items positive in the test);
  • Subjects with other severe systemic diseases;
  • Other subjects that the researchers consider not eligible for inclusion.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital of Xinxiang Medical College — Xinxiang

Идентификаторы

NCT: NCT07580755 · MSCBW-2022

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗