Somatic Stem Cells in Endometriosis

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01412138
• Other study ID #: 1006-C-073-CS-F
• Status: Active, not recruiting
• Phase: N/A
• First received: July 28, 2011
• Last updated: April 21, 2015
• Start date: March 2011
• Est. completion date: April 2016

Study information

• Verified date: April 2015
• Source: Igenomix
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Intervention

Other:
• genetic analysis
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. In vitro culture conditions for cell proliferation. To characterize the somatic stem cell population using techniques of endometriotic cell and molecular biology. Compare the results obtained from patients with endometriosis with control patients (without endometriosis) earlier work by our group.

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Igenomix

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		TWO YEARS	No