Somatic Stem Cells in Endometriosis

April 21, 2015 updated by: Carlos Simon, Igenomix

"Identification, Characterization and Isolation of Somatic Stem Cells in Human Endometrium of Women With Endometriosis"

Human endometrium is a very dynamic tissue characterized by cyclical process of proliferation, differentiation and cellular shedding as part of each menstrual cycle. This issue suggests the presence of somatic stem cells. Endometriosis is characterized by presence of endometrium outside the uterine cavity. The existence of a somatic stem cell population in endometrium could explain the incorrect proliferation of these cells, which would lead to formation of endometriotic foci.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Throughout the life of the woman, the endometrium undergoes a series of continuous modifications that require a highly accurate feedback mechanism and specialized and must be based on the activity of the stem cell population.

Endometriosis is an estrogen-dependent chronic disease characterized by the presence of functional endometrium outside the uterine cavity, mainly in the peritoneum and ovary (Giudice and Kao, 2004). It affects 6-10% of women of reproductive age, often resulting in a series of gynecological problems, including dysmenorrhea, pelvic pain and infertility. The nature of endometriosis suggests that the initiation of ectopic endometrial lesions may be due to stem or progenitor cells, which is consistent with the theory of retrograde menstruation (Starzinski-Powitz et al. 2001; Leyendecker et al. 2002, Gargett, 2006; Gargett, 2007, Sasson and Taylor, 2008). To date, no direct evidence of the role of somatic stem cells of the endometrium in the pathogenesis of endometriosis. However, numerous studies show that ectopic endometrial cells implant in many established models used for the study of endometriosis.(Masuda et al., 2007b; Sasson and Taylor, 2008; Gargett y Masuda.,2010)

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • IVI Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with endometrial infertility factor, undergoing ART.

Description

Inclusion Criteria:

Inclusion criteria for patients with endometriosis:

  1. Female patients with ovarian endometriosis, peritoneal and recto-vaginal.
  2. Aged between 20 and 40.
  3. Signing of informed consent for collection and storage of biological samples.

Exclusion Criteria:

  1. Contraindications for endometrial biopsy.
  2. Failure to sign informed consent for collection and storage of biological samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARM 1
ENDOMETRIAL SAMPLE
Other: genetic analysis
  1. To identify by flow cytometry through technique of "Side Population" the population of somatic stem cells present in both human endometrial eutopic and ectopic endometrium of women with ovarian endometriosis, peritoneal and recto-vaginal.
  2. In vitro culture conditions for cell proliferation.
  3. To characterize the somatic stem cell population using techniques of endometriotic cell and molecular biology.
  4. Compare the results obtained from patients with endometriosis with control patients (without endometriosis) earlier work by our group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterization of endometrial stem cells through Flow Citometry and Side Population techniques and In vitro culture cellular proliferation to then characterize the cell population through molecular and cellular techniques.
Time Frame: TWO YEARS
TWO YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Igenomix

Investigators

  • Principal Investigator: Carlos Simon, MDPhd, IVI Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 9, 2011

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1006-C-073-CS-F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on genetic analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe