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Somatic Stem Cells in Leiomyomas?

Identification and Characterization of Putative Leiomyoma Stem Cells.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01592903
Enrollment
16
Registered
2012-05-07
Start date
2012-04-30
Completion date
2015-12-31
Last updated
2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leiomyomas

Keywords

Uterine fibroids, somatic stem cell, Side Population

Brief 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.

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.

Interventions

GENETICLaparoscopic 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.

Sponsors

Igenomix
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Formation and growth of human leiomyomas36 monthsAssessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026