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Идёт набор NCT05939167

Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

Фаза I / Фаза II С лечением AIDS

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: mesenchymal stem cell, saline.
Кому может быть актуально
Состояния в реестре: AIDS. 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 Double-blind, Randomized Placebo-controlled Clinical Trial to Investigate the Safety and Efficacy of Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage

Обзор

The goal of this study is to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for AIDS patients at late stage.

Подробное описание

Mesenchymal stem cells (MSCs) possess immunomodulatory, anti-inflammatory, and regenerative properties. The safety and effectiveness of MSCs have been investigated in various clinical trials for the treatment of several disorders, including graft-versushost disease, inflammatory bowel disease, and multiple sclerosis. It has been reported that MSC treatment in HIV-infected patients with immunological nonresponders resulted in a significant increase in circulating CD4+ T lymphocytes and a decrease of the activation of T lymphocytes and soluble inflammation mediator levels without significant adverse effects or loss of viremia control. However, the therapeutic efficacy of MSC treatment for AIDS patients at late stage is not well-understood. This study aims to investigate the safety and efficacy of MSC treatment for AIDS patients at late stage.

Вмешательства

  • Препарат mesenchymal stem cell
    Mesenchymal stem cell dose is 0.75-1.0×10\*6/kg and is transplanted by intravenous infusion. For the mesenchymal stem cell standard treatment group, the cells are used for three times(at week 0, 2,4 after recruitment) and the mesenchymal stem cell enhanced treatment group, the cells are used for six times(at week 0, 2,4,24,26,28 after recruitment).
  • Другое saline
    saline is used as placebo in the placebo comparator group

Первичные конечные точки

  • Number of participants with side effects in MSCs treatment groups [Срок оценки: 48 weeks]
  • CD4+ T cell counts after MSCs transfusion [Срок оценки: 48 weeks]
Вторичные конечные точки (1)
  • HIV RNA viral load [Срок оценки: 48 weeks]

Критерии участия

Критерии включения

  • Confirmed HIV infection, aged 18-65, both genders
  • CD4+T count less than 500 cells/ul at baseline.
  • No serious AIDS related events. 3. could understand and sign the informed consent form and comply with the requirements of this study.

4\. agree not to participate in other studies and not to receive other immunotherapies during the period of participation in this study

Критерии исключения

  • have HBV/HCV/HDV/HEV infection, and the virological test is positive.
  • The viral load for CMV and EBV is more than 1000 copies/ML.
  • have HIV-2 infection.
  • have serious complications in organs including renal, circulatory, respiratory, digestive, endocrine, neural and immunological diseases and tumors.
  • received treatment of hormones or other immunosuppressive drugs for a long time.
  • with serious AIDS related or unrelated events.
  • received immunosuppressive drugs or systemic cytotoxic drugs for more than 3 months before recruiting
  • have poor compliance during treatment.
  • drug addiction within 6 months, or the urine drug test is positive
  • participate in other clinical trials currently
  • pregnant, breastfeeding, or have fertility requirements.
  • unable or unwilling to provide informed consents, or unable to comply with research requirements.
  • Other serious situations that may hinder clinical trials.

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 · 4 центра
  • Beijing 302 Hospital — Пекин
  • Beijing YouAn Hospital — Пекин
  • Shenzhen Third People's Hospital — Шэньчжэнь
  • The Fifth Hospital of Shijiazhuang — Shijiazhuang

Идентификаторы

NCT: NCT05939167 · 2022YFC2304403

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗