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Набор скоро начнётся NCT06171906

Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation

Фаза IV С лечением MSC

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 stromal cells.
Кому может быть актуально
Состояния в реестре: MSC. Базовые параметры: 18 лет — 60 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

Clinical Study of MSCs for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation

Обзор

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective approach for treating both benign and malignant blood disorders. It primarily involves high-dose chemotherapy to eliminate tumor cells within the patient's body, as well as to suppress the recipient's hematopoiesis and immune function. The transplantation replaces the recipient's original hematopoietic stem cells (HSCs) with donor-derived HSCs, thereby reconstructing the donor's hematopoietic and immune functions to achieve disease cure. Poor graft function (PGF) following transplantation, which refers to inadequate engraftment of the transplanted hematopoietic stem cells, is one of the major factors limiting the effectiveness of allo-HSCT. Mesenchymal stromal cells (MSCs), identified within the bone marrow stroma, are a type of non-hematopoietic multipotent stem cells. Several studies, including previous research by our research team, suggest that MSCs can improve the bone marrow hematopoietic microenvironment by secreting various cytokines. This leads to the promotion of hematopoietic stem cell proliferation and differentiation, enhancement of hematopoietic function, and support for hematopoiesis as well as direct or indirect promotion of vascular regeneration in damaged tissues and organs. Therefore, exploring the efficacy of umbilical cord-derived MSCs in treating poor graft function after allo-HSCT, observing the recovery of blood parameters in patients with poor engraftment, monitoring transplantation-related complications and immune reconstitution, and conducting preliminary investigations into the underlying mechanisms can contribute to the exploration of new clinical techniques for the treatment of PGF following allo-HSCT.

Вмешательства

  • Биопрепарат mesenchymal stromal cells
    On the basis of conventional PGF treatment for poor implantation, the enrolled patients were injected with 1×10\^6/kg mesenchymal stem cells of cord blood weekly for 4 consecutive weeks

Первичные конечные точки

  • The Hemogram recovery of patients with poor graft function after treatment [Срок оценки: 20~40 days after transplantation]
Вторичные конечные точки (3)
  • Infection rate [Срок оценки: 20~40 days after transplantation]
  • graft-versus-host disease [Срок оценки: within the initial 30 to 60 days or further]
  • survival rate [Срок оценки: 1 year after transplantation]

Критерии участия

Критерии включения

  • Screening patients for allogeneic hematopoietic stem cell transplantation;
  • No gender limit, age ≥18 years old and ≤60 years old;
  • KPS score >60 points, expected survival period >3 months;
  • Those without serious functional damage to important organs throughout the body;
  • The patient has no other contraindications to hematopoietic stem cell transplantation
  • Voluntary test and informed consent.

Критерии исключения

  • Have severe heart, kidney or liver dysfunction;
  • Those combined with other malignant tumors need treatment;
  • There are clinical symptoms of brain dysfunction or severe mental illness and the inability to understand or follow the research protocol;
  • Patients who cannot be guaranteed to complete the necessary treatment plan and follow-up observation;
  • Patients with severe acute allergic reactions;
  • Clinically uncontrolled active infection;
  • Patients who are participating in other clinical trials;
  • Researchers believe that the subject is not suitable for clinical trials for other reasons.

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 · 2 центра
  • Xinqiao Hospital — Чунцин
  • Second Affiliated Hospital, Army Medical University, PLA — Чунцин

Публикации

  • Kong Y, Song Y, Tang FF, Zhao HY, Chen YH, Han W, Yan CH, Wang Y, Zhang XH, Xu LP, Huang XJ. N-acetyl-L-cysteine improves mesenchymal stem cell function in prolonged isolated thrombocytopenia post-allotransplant. Br J Haematol. 2018 Mar;180(6):863-878. doi: 10.1111/bjh.15119. Epub 2018 Feb 2. PMID 29392716
  • Michalicka M, Boisjoli G, Jahan S, Hovey O, Doxtator E, Abu-Khader A, Pasha R, Pineault N. Human Bone Marrow Mesenchymal Stromal Cell-Derived Osteoblasts Promote the Expansion of Hematopoietic Progenitors Through Beta-Catenin and Notch Signaling Pathways. Stem Cells Dev. 2017 Dec 15;26(24):1735-1748. doi: 10.1089/scd.2017.0133. Epub 2017 Nov 27. PMID 29050516

Идентификаторы

NCT: NCT06171906 · MSC4PGF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗