Somatic Stem Cells in Leiomyomas?

NCT01592903 — Completed, 16 participants, Igenomix

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Identification and Characterization of Putative Leiomyoma Stem Cells.

RegistryNCT01592903
StatusCompleted
Study typeObservational
Enrollment16 (Actual)
SponsorIgenomix (Industry)
ConditionsLeiomyomas
InterventionsLaparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma. (Genetic)
Datesstart 2012-04-01, primary completion 2015-12-01, completion 2015-12-01, first posted 2012-05-07, last updated 2016-08-31
Locations1 site in Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Leiomyomas All trials of Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.

-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Patients with symptomatic uterine fibroids.Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.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. (Genetic): * Obtention of one part of removed human leiomyoma after surgery and maintained in 4ÂșC 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.

+Outcome measures

Primary outcomes

  • Formation and growth of human leiomyomas [36 months]: Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.

+Eligibility

Sex: Female, ages: 20 Years to 40 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
IVI ValenciaValencia, ValenciaSpain

+Investigators