Somatic Stem Cells in Leiomyomas?
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|ClinicalTrials.gov Identifier: NCT01592903|
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : August 31, 2016
|Condition or disease||Intervention/treatment|
|Leiomyomas||Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.|
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.
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Identification and Characterization of Putative Leiomyoma Stem Cells.|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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.
Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.
- Formation and growth of human leiomyomas [ Time Frame: 36 months ]Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592903
|Valencia, Spain, 46015|
|Principal Investigator:||Carlos Simon, MDPhD||Igenomix|