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Clinical Trials/NCT01412138
NCT01412138
Unknown
Not Applicable

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

Igenomix1 site in 1 country30 target enrollmentMarch 2011
ConditionsEndometriosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Igenomix
Enrollment
30
Locations
1
Primary Endpoint
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.
Last Updated
11 years ago

Overview

Brief Summary

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

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)

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
April 2016
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Igenomix
Responsible Party
Principal Investigator
Principal Investigator

Carlos Simon

Principal Investigator

Instituto Valenciano de Infertilidad, IVI VALENCIA

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria for patients with endometriosis:
  • Female patients with ovarian endometriosis, peritoneal and recto-vaginal.
  • Aged between 20 and
  • Signing of informed consent for collection and storage of biological samples.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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