Somatic Stem Cells in Leiomyomas?

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Igenomix
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
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification and Characterization of Putative Leiomyoma Stem Cells.

Resource links provided by NLM:


Further study details as provided by Igenomix:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592903

Contacts
Contact: Aymara Mas, MA 34963050900 aramya82@hotmail.com
Contact: Leslie Atkinson, MA 34963050900 leslie.atkinson@ivi.es

Locations
Spain
IVI Valencia Recruiting
Valencia, Spain, 46015
Contact: Leslie Atkinson, MA    34963050900    leslie.atkinson@ivi.es   
Principal Investigator: Carlos Simon, MDPhD         
Sub-Investigator: Aymara Mas, MA         
Sponsors and Collaborators
Igenomix
  More Information

No publications provided

Responsible Party: Carlos Simon, Director of Clinical Research IVI Valencia, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01592903     History of Changes
Other Study ID Numbers: 1006-C-072-CS-F
Study First Received: May 3, 2012
Last Updated: March 26, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by Igenomix:
Uterine fibroids
somatic stem cell
Side Population

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Connective Tissue Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on October 22, 2014