Somatic Stem Cells in Leiomyomas?
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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. |
- 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: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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.
|
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 |
Female patients from 20 years and older undergoing laparoscopic myomectomy for symptomatic uterine fibroids.
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| Contact: Aymara Mas, MA | 34963050900 | aramya82@hotmail.com |
| Contact: Leslie Atkinson, MA | 34963050900 | leslie.atkinson@ivi.es |
| 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 | |
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: | May 7, 2012 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Instituto Valenciano de Infertilidad, Spain:
|
Uterine fibroids somatic stem cell Side Population |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 23, 2013