Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-29 @ 10:02 PM
Study NCT ID:
NCT01592903
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2012-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatic Stem Cells in Leiomyomas?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2012-05-03', 'studyFirstSubmitQcDate': '2012-05-04', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Formation and growth of human leiomyomas', 'timeFrame': '36 months', 'description': 'Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uterine fibroids', 'somatic stem cell', 'Side Population'], 'conditions': ['Leiomyomas']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The organ of interest in our study is the myometrium, a muscle layer of the uterus located between the perimetry and the endometrium.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients from 20 years and older undergoing laparoscopic myomectomy for symptomatic uterine fibroids.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis for subserosal, intramural and submucosal fibroids.\n* Aged between 20 and 40 years\n* Signing of informed consent for collection and storage of biological samples.\n\nExclusion criteria:\n\n* Contraindications for surgery.\n* Failure to sign informed consent for collection and storage of biological samples.'}, 'identificationModule': {'nctId': 'NCT01592903', 'briefTitle': 'Somatic Stem Cells in Leiomyomas?', 'organization': {'class': 'INDUSTRY', 'fullName': 'Igenomix'}, 'officialTitle': 'Identification and Characterization of Putative Leiomyoma Stem Cells.', 'orgStudyIdInfo': {'id': '1006-C-072-CS-F'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with symptomatic uterine fibroids.', 'description': 'Samples of human leiomyomas are obtained from patients undergoing laparoscopic myomectomy for symptomatic uterine fibroids. These leiomyomas are isolated and cultured for stem cells.', 'interventionNames': ['Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.']}], 'interventions': [{'name': 'Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.', 'type': 'GENETIC', 'description': '* Obtention of one part of removed human leiomyoma after surgery and maintained in 4ºC until procedures.\n* Sample digestion through controlled enzymes.\n* Isolated the "Side Population" from leiomyoma cell suspension by Flow cytometry .\n* Culture of these cells.\n* Morphological and genetic characterization.\n* Assessment of pluripotent potential from isolated cells.\n* Analysis of the degree of functionality.', 'armGroupLabels': ['Patients with symptomatic uterine fibroids.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'IVI Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Carlos Simon, MDPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Igenomix'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Igenomix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Research IVI Valencia', 'investigatorFullName': 'Carlos Simon', 'investigatorAffiliation': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}}}}