Somatic Stem Cells in Leiomyomas?

NCT ID: NCT01592903

Last Updated: 2016-08-31

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

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC) responsible for the formation and growth of leiomyomas using the Side Population method.

Detailed Description

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The organ of interest in our study is the myometrium, a muscle layer of the uterus located between the perimetry and the endometrium.

The investigators try to identify, locate and characterize the myometrial stem cell population in the uterine fibroids by isolation of "Side Population" by flow cytometry. Once the investigators achieve the purposes to set out, the investigators would try to maintain "in vitro" stem cell population isolated from myometrial fibroids, for further endocrine characterization. Finally, the investigators would try to induce the formation of fibroids in murine models as a first step to demonstrate that the origin of these formations is due to the abnormal proliferation of myometrial adult stem cells. The results of this study will allow the identification of the cell population in the fibroids. The investigators also can being able to compare with the myometrium in order to establish a relationship that helps us to understand more about the pathophysiology of this disease, using these stem cells as targets therapy in the treatment of this myometrium condition.

Conditions

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Leiomyomas

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with symptomatic uterine fibroids.

Samples of human leiomyomas are obtained from patients undergoing laparoscopic myomectomy for symptomatic uterine fibroids. These leiomyomas are isolated and cultured for stem cells.

Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.

Intervention Type GENETIC

* Obtention of one part of removed human leiomyoma after surgery and maintained in 4ºC until procedures.
* Sample digestion through controlled enzymes.
* Isolated the "Side Population" from leiomyoma cell suspension by Flow cytometry .
* Culture of these cells.
* Morphological and genetic characterization.
* Assessment of pluripotent potential from isolated cells.
* Analysis of the degree of functionality.

Interventions

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Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.

* Obtention of one part of removed human leiomyoma after surgery and maintained in 4ºC until procedures.
* Sample digestion through controlled enzymes.
* Isolated the "Side Population" from leiomyoma cell suspension by Flow cytometry .
* Culture of these cells.
* Morphological and genetic characterization.
* Assessment of pluripotent potential from isolated cells.
* Analysis of the degree of functionality.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis for subserosal, intramural and submucosal fibroids.
* Aged between 20 and 40 years
* Signing of informed consent for collection and storage of biological samples.

Exclusion Criteria

* Contraindications for surgery.
* 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

Director of Clinical Research IVI Valencia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Simon, MDPhD

Role: PRINCIPAL_INVESTIGATOR

Igenomix

Locations

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IVI Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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1006-C-072-CS-F

Identifier Type: -

Identifier Source: org_study_id

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