Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-02-06 @ 6:11 PM
Study NCT ID:
NCT01345227
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2011-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Marrow as an Alternative Site for Islet Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events related to the procedure of intra bone marrow islet infusion', 'timeFrame': 'up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Beta-cell function', 'timeFrame': 'up to 3 years', 'description': 'Beta-cell function will be assessed by fasting C peptide, HbA1c,glycaemia, change in average daily insulin requirements, basal (fasting) and -10 to 120 min time course of glucose, C-peptide and insulin derived from the arginine test, beta-score and Transplant Estimated Function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'islet transplantation', 'autotransplantation'], 'conditions': ['Type 1 Diabetes', 'Postpancreatectomy Hyperglycemia']}, 'referencesModule': {'references': [{'pmid': '19773545', 'type': 'BACKGROUND', 'citation': 'Cantarelli E, Melzi R, Mercalli A, Sordi V, Ferrari G, Lederer CW, Mrak E, Rubinacci A, Ponzoni M, Sitia G, Guidotti LG, Bonifacio E, Piemonti L. Bone marrow as an alternative site for islet transplantation. Blood. 2009 Nov 12;114(20):4566-74. doi: 10.1182/blood-2009-03-209973. Epub 2009 Sep 22.'}, {'pmid': '20719074', 'type': 'BACKGROUND', 'citation': 'Ciceri F, Piemonti L. Bone marrow and pancreatic islets: an old story with new perspectives. Cell Transplant. 2010;19(12):1511-22. doi: 10.3727/096368910X514279. Epub 2010 Aug 17.'}, {'pmid': '23733196', 'type': 'RESULT', 'citation': 'Maffi P, Balzano G, Ponzoni M, Nano R, Sordi V, Melzi R, Mercalli A, Scavini M, Esposito A, Peccatori J, Cantarelli E, Messina C, Bernardi M, Del Maschio A, Staudacher C, Doglioni C, Ciceri F, Secchi A, Piemonti L. Autologous pancreatic islet transplantation in human bone marrow. Diabetes. 2013 Oct;62(10):3523-31. doi: 10.2337/db13-0465. Epub 2013 Jun 3.'}, {'pmid': '30130323', 'type': 'DERIVED', 'citation': 'Maffi P, Nano R, Monti P, Melzi R, Sordi V, Mercalli A, Pellegrini S, Ponzoni M, Peccatori J, Messina C, Nocco A, Cardillo M, Scavini M, Magistretti P, Doglioni C, Ciceri F, Bloem SJ, Roep BO, Secchi A, Piemonti L. Islet Allotransplantation in the Bone Marrow of Patients With Type 1 Diabetes: A Pilot Randomized Trial. Transplantation. 2019 Apr;103(4):839-851. doi: 10.1097/TP.0000000000002416.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate safety and feasibility of bone marrow (BM) as site for islet transplantation (Tx) in humans. The investigators hypothesis is that BM represents a better site than liver thanks to its potential capacity to favor islet engraftment in face of a more easiness of access and bioptic follow up.', 'detailedDescription': "We were permitted to perform single intra BM islet infusion at the level of the iliac crest in patients having contraindications for intraportal infusion. A needle for BM aspiration (14 G) is inserted into the superior-posterior iliac crest and islet suspension (1:2.5; tissue:Ringer's Lactate solution) is infused. The entire intraBM-injection procedure lasted 8-15 min from the beginning of anaesthesia (short propofol sedation)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic patients eligible for pancreatic islet transplantation based on local accepted practice and guidelines. This includes at least: a)clinical history compatible with T1D with insulin-dependence for \\>5 years; b) undetectable stimulated (arginine or MMTT) C-peptide levels (\\<0.3 ng/mL) in the 12 months before transplant c)presence of severe hypoglycaemic events\n* patients undergoing total pancreatectomy because of anastomosis leakage after pancreatoduodenectomy or because of pancreatic anastomosis is made impracticable by technical difficulties and/or high risk of leakage.\n* presence of contraindications for intraportal islet infusion\n\nExclusion Criteria:\n\n* presence of hematologic disease'}, 'identificationModule': {'nctId': 'NCT01345227', 'briefTitle': 'Bone Marrow as an Alternative Site for Islet Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Pilot Study to Assess Feasibility and Safety of Bone Marrow as Alternative Site in Islet Transplant Patients', 'orgStudyIdInfo': {'id': 'BMT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra BM islet infusion', 'description': 'single intra BM islet infusion at the level of the iliac crest will be performed in patients having contraindications for intraportal infusion', 'interventionNames': ['Procedure: Intra bone marrow islet infusion']}], 'interventions': [{'name': 'Intra bone marrow islet infusion', 'type': 'PROCEDURE', 'description': "A needle for bone marrow aspiration (14 G) will be inserted into the superior-posterior iliac crest and islet suspension (1:2.5; tissue:Ringer's Lactate solution) will be infused. The entire intraBM-injection procedure last 8-15 min from the beginning of anaesthesia (short propofol sedation).", 'armGroupLabels': ['Intra BM islet infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Lorenzo Piemonti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Centro San Raffaele del Monte Tabor'}, {'name': 'Paola Maffi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fondazione Centro San Raffaele del Monte Tabor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Islet Transplantation Program', 'investigatorFullName': 'Piemonti Lorenzo', 'investigatorAffiliation': 'Ospedale San Raffaele'}}}}