Somatic Stem Cells in Leiomyomas?

NCT01592903 | Completed

• 1 other identifier: 1006-C-072-CS-F
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Leiomyomas

Keywords

Uterine fibroids; somatic stem cell; Side Population

Outcome Measures

Primary Outcomes (1)

• Formation and growth of human leiomyomas

  Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.

  36 months

Study Arms (1)

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.

Interventions

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

* 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.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Contraindications for surgery.
• Failure to sign informed consent for collection and storage of biological samples.

Sponsors & Collaborators

• Igenomix: lead

Study Sites (1)

IVI Valencia

Valencia, Valencia, 46015, Spain

Location

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.

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Carlos Simon, MDPhD

  Igenomix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research IVI Valencia

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

ES (1)