View Clinical Trial (Medical Research Study)
Bone Marrow Cell Engraftment of the Uterus
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Endometriosis - Stem Cell Transplant - Healthy - Infertility - Asherman's Syndrome - Reproductive Disorders - Recurrent Pregnancy Loss |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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- INCLUSION CRITERIA:
Subject is able to give consent/assent to participate in the protocol.
Listed below are acceptable medical conditions for inclusion in this protocol:
- Age greater than or equal to 18 years old
- Female gender
- Presence of a uterus
- Fall into one of the following categories:
- Healthy volunteers
- Hematologic patients:
- Whole bone marrow transplant recipients
- Peripheral blood stem cell transplant recipients
- Mesenchymal stem cell transplant recipients
- Bone marrow or stem cell donors
- Fully ablative transplant recipients
- Nonmyeloablative transplant recipients
- Cord blood transplant recipients
Rare, interesting, or unique reproductive phenotypes that may provide insight to
endometrial function in health and disease:
- Asherman's syndrome
- Endometriosis
- Abnormal uterine bleeding
- Recurrent pregnancy loss
- Infertility
- Implantation failure
- Reproductive disorders
EXCLUSION CRITERIA:
- Unable to comprehend the investigational nature of the protocol participation.
- Positive pregnancy test.
- Anticoagulation or known coagulopathy.
- Active gonorrhea or Chlamydia infections or pelvic inflammatory disease within the
last 3 months.
- Previous hysterectomy or endometrial ablation procedure.
- Thrombocytopenia (< 50,000).
- Uterine or cervical cancer.
- Cervical stenosis.
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| NCT ID: |
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NCT01468935 |
| Primary Contact: |
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Principal Investigator
Erin F Wolff, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Erin F Wolff, M.D.
Phone: (301) 496-5800
Email: wolffe@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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