Healthy Volunteers Clinical Trial
Official title:
Bone Marrow Cell Engraftment of the Uterus and Genetic Studies of Reproductive Functioning
Verified date | September 21, 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | September 21, 2017 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Bhanu NV, Trice TA, Lee YT, Gantt NM, Oneal P, Schwartz JD, Noel P, Miller JL. A sustained and pancellular reversal of gamma-globin gene silencing in adult human erythroid precursor cells. Blood. 2005 Jan 1;105(1):387-93. Epub 2004 Sep 14. — View Citation
Ogawa M, LaRue AC, Drake CJ. Hematopoietic origin of fibroblasts/myofibroblasts: Its pathophysiologic implications. Blood. 2006 Nov 1;108(9):2893-6. Epub 2006 Jul 13. Review. — View Citation
Taylor HS. Endometrial cells derived from donor stem cells in bone marrow transplant recipients. JAMA. 2004 Jul 7;292(1):81-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To study if endometiral stem cells are different in normal and disease states. | |||
Secondary | To study if the type of hematopoietic transplantation regimen affects uterine engraftment of donor stem cells. |
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