Study Results
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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COMPLETED
16 participants
OBSERVATIONAL
2012-04-30
2015-12-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_ONLY
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.
* 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.
Eligibility Criteria
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Inclusion Criteria
* Aged between 20 and 40 years
* Signing of informed consent for collection and storage of biological samples.
Exclusion Criteria
* Failure to sign informed consent for collection and storage of biological samples.
20 Years
40 Years
FEMALE
Yes
Sponsors
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Igenomix
INDUSTRY
Responsible Party
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Carlos Simon
Director of Clinical Research IVI Valencia
Principal Investigators
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Carlos Simon, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Igenomix
Locations
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IVI Valencia
Valencia, Valencia, Spain
Countries
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Other Identifiers
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1006-C-072-CS-F
Identifier Type: -
Identifier Source: org_study_id
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