Somatic Stem Cells in Endometriosis

NCT ID: NCT01412138

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Endometriosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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ARM 1

ENDOMETRIAL SAMPLE

genetic analysis

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Igenomix

INDUSTRY

Sponsor Role lead

Responsible Party

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Carlos Simon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Simon, MDPhd

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

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IVI Valencia

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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1006-C-073-CS-F

Identifier Type: -

Identifier Source: org_study_id

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