AzTrials
AzTrials

EndometriosisNCT01468935

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

An observational study of Endometriosis and Stem Cell Transplant, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
How many people
79 participants
Where
1 siteUnited States
Study dates
31 Oct 2011to 21 Sep 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 23Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.
Read more

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.
Read the 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.

Keywords
Uterus, Endometrium, Bone Marrow Transplant, Gynecology, Healthy Volunteer, HV, Stem Cell Transplant, Endometriosis
Medical subject headings
Endometriosis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2011 (estimated)
  2. Study start31 Oct 2011
  3. Study completion21 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01468935
Sponsor's protocol ID
120016
Other IDs
12-CH-0016
Status last verified
21 Sep 2017
First submitted
8 Nov 2011
Last updated
17 Dec 2019
Results posted
No

Publications

  • 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. doi: 10.1182/blood-2004-04-1599. Epub 2004 Sep 14.

    PubMed 15367428

  • Ogawa M, LaRue AC, Drake CJ. Hematopoietic origin of fibroblasts/myofibroblasts: Its pathophysiologic implications. Blood. 2006 Nov 1;108(9):2893-6. doi: 10.1182/blood-2006-04-016600. Epub 2006 Jul 13.

    PubMed 16840726

  • Taylor HS. Endometrial cells derived from donor stem cells in bone marrow transplant recipients. JAMA. 2004 Jul 7;292(1):81-5. doi: 10.1001/jama.292.1.81.

    PubMed 15238594

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis and Stem Cell Transplant, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To study if endometiral stem cells are different in normal and disease states.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01468935, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in