Somatic Stem Cells in Leiomyomas?
- Conditions
- Leiomyomas
- Interventions
- Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.
- Registration Number
- NCT01592903
- Lead Sponsor
- Igenomix
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with symptomatic uterine fibroids. 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.
- Primary Outcome Measures
Name Time Method Formation and growth of human leiomyomas 36 months Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IVI Valencia
🇪🇸Valencia, Spain