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临床试验/NCT01468935
NCT01468935已完成不适用

Bone Marrow Cell Engraftment of the Uterus and Genetic Studies of Reproductive Functioning

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2011年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
试验地点
1
主要终点
To study if endometiral stem cells are different in normal and disease states.

研究概览

简要总结

Background:

  • Some transplant recipients have been found to have cells in their uterus that come from the donor. Researchers want to study uterine tissue from three different groups of women: (1) healthy volunteers, (2) people who have had a stem cell transplant, and (3) people with rare diseases or conditions that affect reproduction. These samples will help researchers learn more about the way stem cells work in the reproductive tract.

Objectives:

  • To collect cells from the uterus to study how stem cells work in the reproductive tract.

Eligibility:

  • Women at least 18 years of age.

Design:

  • Participants will be screened with a physical exam and medical history. They will also have blood and urine tests.
  • Participants will have an endometrial biopsy to collect cells for study. The biopsy visit will take 1 to 2 hours.

详细描述

Transplantation with hematopoietic cells has been used for a wide variety of blood disorders, but also for diseases like solid organ cancers. Interestingly, women who have had bone marrow transplants have been found to have donor tissue in their endometrium, which raises the possibility of cellular therapies using bone marrow derived cells for gynecologic indications. Donor engraftment does not appear to occur when transplantations were performed with stem cells collected from peripheral blood of the donor. Therefore, the subtype of cells from the bone marrow responsible for engraftment is not yet known, nor is the ideal transplantation regimen known.

The immediate aim of this tissue procurement protocol is to obtain endometrial (uterine) stem cells from many human volunteers in order to examine the biological properties of those cells. We will collect tissue from 3 primary groups of patients: normal controls, patients with rare diseases or reproductive disorders, and patients who have undergone hematopoietic stem cell transplant. Each volunteer will undergo an endometrial biopsy during an office visit. The endometrial tissue will then be studied for a better understanding of their biological properties, growth and differentiation. One specific area of interest is to study how hematopoietic transplantation impacts endometrial cell function. These endometrial cells will be analyzed in-depth in the laboratory to determine if they came from the donor or recipient, and if so, which specific populations of cells. Hematologic pre-transplant conditioning information will be correlated with these research studies to identify factors that may assist with the understanding of adult endometrial stem cell biology.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To study if endometiral stem cells are different in normal and disease states.

次要结局

  • To study if the type of hematopoietic transplantation regimen affects uterine engraftment of donor stem cells.

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih
责任方
Sponsor

研究点 (1)

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