Somatic Stem Cells in Leiomyomas?

This study is currently recruiting participants.
Verified March 2014 by Iviomics
Sponsor:
Information provided by (Responsible Party):
Carlos Simon, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01592903
First received: May 3, 2012
Last updated: March 26, 2014
Last verified: March 2014

May 3, 2012
March 26, 2014
April 2012
September 2014   (final data collection date for primary outcome measure)
Formation and growth of human leiomyomas [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.
Same as current
Complete list of historical versions of study NCT01592903 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Somatic Stem Cells in Leiomyomas?
Identification and Characterization of Putative Leiomyoma Stem Cells.

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

PHASE 1:SAMPLE COLLECTION Duration: From the first month to 36th month approximately. PHASE 2: CELL PREPARATION PROTOCOL Duration: From the first month to 12th month PHASE 3: ISOLATION OF PUTATIVE SOMATIC STEM CELLS Duration: From the third month (March 2010) to 12th month PHASE 4: CELL CULTURE Duration: From the sixth month to 18th month PHASE 5: ENDOCRINE CHARACTERIZATION Duration:From the 18th month to 36th month Biospecimen Retention Samples With DNA - samples retained, with potential for extraction of DNA from at least one of the types of samples retained (e.g., frozen tissue, whole blood) Biospecimen Description Samples of human leiomyomas obtained from patients with symptomatic uterine fibroids.

Probability Sample

Female patients from 20 years and older undergoing laparoscopic myomectomy for symptomatic uterine fibroids.

Leiomyomas
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.
Patients with symptomatic uterine fibroids.
Samples of human leiomyomas are obtained from patients undergoing laparoscopic myomectomy for symptomatic uterine fibroids. These leiomyomas are isolated and cultured for stem cells.
Intervention: Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Female
20 Years to 40 Years
Yes
Contact: Aymara Mas, MA 34963050900 aramya82@hotmail.com
Contact: Leslie Atkinson, MA 34963050900 leslie.atkinson@ivi.es
Spain
 
NCT01592903
1006-C-072-CS-F
No
Carlos Simon, Instituto Valenciano de Infertilidad, Spain
Iviomics
Not Provided
Not Provided
Iviomics
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP