Somatic Stem Cells in Leiomyomas?

Leiomyomas Clinical Trial

Official title:

Identification and Characterization of Putative Leiomyoma Stem Cells.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592903
• Other study ID #: 1006-C-072-CS-F
• Status: Completed
• Phase: N/A
• First received: May 3, 2012
• Last updated: August 30, 2016
• Start date: April 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Igenomix
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyomas

Intervention

Genetic:
• Laparoscopic 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.

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Igenomix

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formation and growth of human leiomyomas	Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.	36 months	No