Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT03051308
Status:
UNKNOWN
Last Update Posted:
2017-02-13
First Post:
2017-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C055206', 'term': 'University of Wisconsin-lactobionate solution'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2017-01-29', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cell viability of Parathyroid cells after isolation process', 'timeFrame': '0 hour', 'description': 'After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory.\n\nThen the investigators will measure the viability of Parathyroid cells after isolation process.'}, {'measure': 'Cell viability of Parathyroid cells after 6 hour of cold ischemia', 'timeFrame': '6 hour', 'description': 'After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 6 hours the investigators will measure the viability of Parathyroid cells after isolation process.'}, {'measure': 'Cell viability of Parathyroid cells after 12 hour of cold ischemia', 'timeFrame': '12 hour', 'description': 'After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 12 hours the investigators will measure the viability of Parathyroid cells after isolation process.'}, {'measure': 'Cell viability of Parathyroid cells after 18 hour of cold ischemia', 'timeFrame': '18 hour', 'description': 'After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 18 hours the investigators will measure the viability of Parathyroid cells after isolation process.'}, {'measure': 'Cell viability of Parathyroid cells after 24 hour of cold ischemia', 'timeFrame': '24 hour', 'description': 'After removal of hyperplastic parathyroid glands, each gland will keep in ice cold NPTS and UW solution for transportation to laboratory. After 24 hours the investigators will measure the viability of Parathyroid cells after isolation process.'}], 'secondaryOutcomes': [{'measure': 'Parathormone Release of Parathyroid Cells', 'timeFrame': '1 day', 'description': 'The investigators will measure the parathormone level from cultured parathyroid cells'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parathyroid cell viability', 'Ischemia', 'Parathyroid allotransplantation', 'Vitamin D Receptor', 'Calcium Sensing Receptor'], 'conditions': ['Parathyroid Allotransplantation']}, 'referencesModule': {'references': [{'pmid': '3282347', 'type': 'BACKGROUND', 'citation': 'Belzer FO, Southard JH. Principles of solid-organ preservation by cold storage. Transplantation. 1988 Apr;45(4):673-6. doi: 10.1097/00007890-198804000-00001. No abstract available.'}, {'pmid': '1689516', 'type': 'BACKGROUND', 'citation': 'Southard JH, van Gulik TM, Ametani MS, Vreugdenhil PK, Lindell SL, Pienaar BL, Belzer FO. Important components of the UW solution. Transplantation. 1990 Feb;49(2):251-7. doi: 10.1097/00007890-199002000-00004.'}, {'pmid': '21566713', 'type': 'BACKGROUND', 'citation': 'Guibert EE, Petrenko AY, Balaban CL, Somov AY, Rodriguez JV, Fuller BJ. Organ Preservation: Current Concepts and New Strategies for the Next Decade. Transfus Med Hemother. 2011;38(2):125-142. doi: 10.1159/000327033. Epub 2011 Mar 21.'}, {'pmid': '24311404', 'type': 'BACKGROUND', 'citation': 'Voigt MR, DeLario GT. Perspectives on abdominal organ preservation solutions: a comparative literature review. Prog Transplant. 2013 Dec;23(4):383-91. doi: 10.7182/pit2013100.'}]}, 'descriptionModule': {'briefSummary': 'Compare the functionality of new parathyroid transport solution (NPTS) with University of Wisconsin Solution (UW) on parathyroid glands. Also assess its effects on cell viability, parathormone (PTH) secretion, calcium-sensing receptor (CaSR) and vitamin D receptor (VDR) levels during cold ischemia.', 'detailedDescription': 'Parathormone (PTH) and vitamin D are two critical hormonal regulators of calcium homeostasis. There is an important relationship between the PTH release and vitamin D receptor for controlling hormonal systems. Also calcium-sensing receptor plays a crucial role in regulating parathormone secretion which means controlling the calcium-dependent systemic ion homeostasis.\n\nCold ischemia protects organs and tissues by slowing their metabolism. The cold ischemia of the transplant tissue is a very important process. The University of Wisconsin (UW) solution substantially improves graft preservation and consequently increases patient survival. The researchers newly developed NPTS for transportation of parathyroid glands.\n\nFor the comparision the researchers measured the parathyroid cell viability and the calcium sensing and vitamin D receptor density of the parathyroid cells at the 0, 6, 12 and 24 hours of cold ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have parathyroid hyperplasia due to chronic renal failure.\n\nExclusion Criteria:\n\n* Patients who refused to join the study\n* Patients younger than 18 years and older than 80 years.\n* Patients who have hepatitis B,\n* Patients who have hepatitis C,\n* Patients who have human immunodeficiency virus (HIV).'}, 'identificationModule': {'nctId': 'NCT03051308', 'briefTitle': 'University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation', 'organization': {'class': 'OTHER', 'fullName': 'SB Istanbul Education and Research Hospital'}, 'officialTitle': 'University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation: Effects on Calcium Sensing and Vitamin D Receptor During Cold Ischemia', 'orgStudyIdInfo': {'id': 'BAVUvsUW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First Application in Hour 0', 'description': "Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\\^7 cells) at 'First Application in Hour 0' non-cold ischemia tissue group", 'interventionNames': ['Combination Product: NPT and UW Solution']}, {'type': 'EXPERIMENTAL', 'label': 'First Application in Hour 6', 'description': "Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\\^7 cells) at 'First Application in Hour 6' cold ischemic tissue group", 'interventionNames': ['Combination Product: NPT and UW Solution']}, {'type': 'EXPERIMENTAL', 'label': 'First Application in Hour 12', 'description': "Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\\^7 cells) at 'First Application in Hour 12' cold ischemic tissue group", 'interventionNames': ['Combination Product: NPT and UW Solution']}, {'type': 'EXPERIMENTAL', 'label': 'First Application in Hour 18', 'description': "Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\\^7 cells) at 'First Application in Hour 18' cold ischemic tissue group", 'interventionNames': ['Combination Product: NPT and UW Solution']}, {'type': 'EXPERIMENTAL', 'label': 'First Application in Hour 24', 'description': "Viability, Calcium-sensing receptor, Vitamin D receptor and parathormone levels of Parathyroid cells (10\\^7 cells) at 'First Application in Hour' 24 cold ischemic tissue group", 'interventionNames': ['Combination Product: NPT and UW Solution']}], 'interventions': [{'name': 'NPT and UW Solution', 'type': 'COMBINATION_PRODUCT', 'description': 'Tissue preservation solutions for transplantation', 'armGroupLabels': ['First Application in Hour 0', 'First Application in Hour 12', 'First Application in Hour 18', 'First Application in Hour 24', 'First Application in Hour 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Erhan Aysan, Prof. M.D.', 'role': 'CONTACT', 'email': 'erhanaysan@hotmail.com', 'phone': '+902124531700', 'phoneExt': '2465'}, {'name': 'Beyza Goncu, Msc', 'role': 'CONTACT', 'email': 'bsgoncu@gmail.com', 'phone': '+902124531700', 'phoneExt': '1465'}], 'facility': 'Bezmialem Vakif University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Erhan Aysan, Prof. M.D.', 'role': 'CONTACT', 'email': 'erhanaysan@hotmail.com', 'phone': '+902124531700', 'phoneExt': '2465'}, {'name': 'Beyza Goncu, Msc', 'role': 'CONTACT', 'email': 'bsgoncu@gmail.com', 'phone': '+902124531700', 'phoneExt': '1465'}], 'overallOfficials': [{'name': 'Erhan Aysan, Prof. M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SB Istanbul Education and Research Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bezmialem Vakif University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erhan Aysan', 'investigatorAffiliation': 'SB Istanbul Education and Research Hospital'}}}}