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Идёт набор NCT07115082

Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Фаза I / Фаза II С лечением Premature Ovarian Insufficiency

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: Climen 21 Tablets, hA-MSCs.
Кому может быть актуально
Состояния в реестре: Premature Ovarian Insufficiency. Базовые параметры: 20 лет — 40 лет · Женщины.
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

A Randomized, Open-label, Parallel-controlled Clinical Study of Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Обзор

There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of human Amniotic mesenchymal stem cells (hA-MSCs) therapy in women suffering from POI.

Подробное описание

This clinical trial is designed to understand the safety and effectiveness of human amniotic membrane mesenchymal stem cells (hA-MSCs) in the treatment of primary ovarian insufficiency (POI). Human amniotic MSCs were infused back into the patients by intravenous injection. The trial was designed with two groups, 1) the control group by conventional hormone replacement therapy with oral Climen and 2) the stem cell treatment group by intravenous infusion of human amniotic membrane mesenchymal stem cells (hA-MSCs) combined with oral Climen hormone therapy. Patients were followed up every 2 weeks after the post-injection stem cells to observe their outcomes. The investigators focused on safety indicators, but also monitored hormone levels and signs of follicular growth to initially assess the effectiveness of the stem cells.

Вмешательства

  • Препарат Climen 21 Tablets
    Climen is commonly used clinically as a hormone replacement therapy and was administered to all patients in both the control and experimental groups in this project.
  • Биопрепарат hA-MSCs
    The patients who were part of the experimental group were administered oral Clomid medication in conjunction with a combined intravenous injection of human amniotic MSCs.

Первичные конечные точки

  • Temperature [Срок оценки: Up to 24 weeks]
  • Pulse [Срок оценки: up to 24 weeks]
  • Breaths per minute [Срок оценки: up to 24 weeks]
  • Blood pressure [Срок оценки: 0-24 weeks]
Вторичные конечные точки (5)
  • Follicle-stimulating hormone (FSH) serum level [Срок оценки: Up to 24 weeks]
  • Estradiol (E2) serum level [Срок оценки: Up to 24 weeks]
  • Anti-Mullerian hormone (AMH) serum level [Срок оценки: up to 24 weeks]
  • Number of antral follicle [Срок оценки: up to 24 weeks]
  • Achievement of pregnancy [Срок оценки: up to 12 months]

Критерии участия

Критерии включения

  • The intention of pregnant women aged >= 20 and < 40, with normal karyotype;
  • Oligo/amenorrhea for at least 4 months;
  • Elevated FSH level >25 IU/l on two occasions >4 weeks apart;
  • Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;
  • Voluntary participation in the study with signed informed consent;

Критерии исключения

  • Unable to follow the treatment observation process required by the trial;
  • Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;
  • With breast, uterine, ovarian tumors, or any other benign or malignant tumors;
  • Allergic history to drugs or any other things;
  • Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.
  • Have undergone ovariectomy or have organic gynaecological diseases.
  • Presence of other gynaecological endocrine diseases such as polycystic ovary syndrome.
  • Severe functional impairment of vital organs.
  • High risk factors for venous thromboembolism and abnormalities in coagulation mechanisms.
  • Attending doctor considers inappropriate to take part in.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT07115082 · CHEC2023-172

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗