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Completed

NCT Number: NCT01592903

Somatic Stem Cells in Leiomyomas?

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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Key information

Conditions

Leiomyomas Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

IVI Valencia

Valencia, 46015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Igenomix

Industry

Registry information

Official study title

Identification and Characterization of Putative Leiomyoma Stem Cells.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 7, 2012
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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