Bone Marrow Cell Engraftment of the Uterus

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01468935
First received: November 8, 2011
Last updated: July 23, 2014
Last verified: August 2013
  Purpose

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.

Condition
Endometriosis
Stem Cell Transplant
Healthy Volunteers

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Bone Marrow Cell Engraftment of the Uterus

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To study if endometiral stem cells are different in normal and disease states.

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

Estimated Enrollment: 100
Study Start Date: October 2011
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468935

Contacts
Contact: Erin F Wolff, M.D. (301) 496-5800 erin.wolff@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Erin F Wolff, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01468935     History of Changes
Other Study ID Numbers: 120016, 12-CH-0016
Study First Received: November 8, 2011
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Uterus
Endometrium
Bone Marrow Transplant
Gynecology
Healthy Volunteer
HV
Stem Cell Transplant
Endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 01, 2014