Somatic Stem Cells in Leiomyomas?

Igenomix

Status: Completed

Conditions: Leiomyomas

Treatments: Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.

Study type: Observational

Funder types: Industry

Identifiers

NCT01592903

1006-C-072-CS-F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: 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.

Trial design

16 participants in 1 patient group

Patients with symptomatic uterine fibroids.

Description:

Samples of human leiomyomas are obtained from patients undergoing laparoscopic myomectomy for symptomatic uterine fibroids. These leiomyomas are isolated and cultured for stem cells.

Treatment:

Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.