LeiomyomasNCT01592903
Somatic Stem Cells in Leiomyomas?
An observational study of Leiomyomas, run by Igenomix at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyomas
- What is being tested?
- Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female patients from 20 years and older undergoing laparoscopic myomectomy for symptomatic uterine fibroids.
Who may be able to join
- 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.
Who cannot join
- Contraindications for surgery.
- Failure to sign informed consent for collection and storage of biological samples.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Leiomyomas
- Being tested
- Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.
- Keywords
- Uterine fibroids, somatic stem cell, Side Population
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formation and growth of human leiomyomas
Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Carlos Simon, MDPhD, Principal investigator, Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592903
- Sponsor's protocol ID
- 1006-C-072-CS-F
- Status last verified
- Aug 2016
- First submitted
- 3 May 2012
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of Putative Leiomyoma Stem Cells.
- ClinicalTrials.gov ID
- NCT01592903
- Acronym / sponsor ID
- 1006-C-072-CS-F
- Conditions
- Leiomyomas
- Keywords
- Uterine fibroids, somatic stem cell, Side Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with symptomatic uterine fibroids. | – | Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.Samples of human leiomyomas are obtained from patients undergoing laparoscopic myomectomy for symptomatic uterine fibroids. These leiomyomas are isolated and cultured for stem cells. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female patients from 20 years and older undergoing laparoscopic myomectomy for symptomatic uterine fibroids.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindications for surgery.
- Failure to sign informed consent for collection and storage of biological samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Genetic | Patients with symptomatic uterine fibroids. |
Primary outcome
Formation and growth of human leiomyomas
Time frame: 36 months
Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
Related trials for Leiomyomas
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingObservational study
The Effects of Uterine Fibroids on Pregnancy in Women
Female Infertility, Uterine Fibroid
RecruitingObservational study
Epidemiology and Risk Factors of Uterine Fibroids in China
Uterine Fibroid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Simon, MDPhD principal investigator
Igenomix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyomas, run by Igenomix at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Formation and growth of human leiomyomas (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.