Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-29 @ 12:58 AM
Study NCT ID:
NCT00730561
Status:
COMPLETED
Last Update Posted:
2008-08-08
First Post:
2008-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}], 'ancestors': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-07', 'studyFirstSubmitDate': '2008-07-31', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in nerve conduction velocity', 'timeFrame': 'Three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nerve conduction velocity', 'hematopoietic stem cell transplantation'], 'conditions': ['Limb Ischemia', 'Diabetic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '16123483', 'type': 'BACKGROUND', 'citation': 'Huang P, Li S, Han M, Xiao Z, Yang R, Han ZC. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care. 2005 Sep;28(9):2155-60. doi: 10.2337/diacare.28.9.2155.'}]}, 'descriptionModule': {'briefSummary': 'Several pathophysiological theories have been proposed for the development of diabetic chronic complications. In recent years, the use of stem cells (totipotential, hematopoietic or endothelial lineages) has been reported as an adjunctive modality of treatment for ischemia models in animals and humans. Nevertheless, there are no reports in the use of stem cells for the treatment of human sensorimotor peripheral diabetic neuropathy. We performed this study to evaluate the effect of autologous hematopoietic CD34+ cell transplantation on nerve conduction velocity in patients with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory patients with type 2 diabetes mellitus and ischemia of one or both lower limbs, defined as lack of limb improvement with conventional care (medications, debridements) after a recent amputation or a patient graded III or IV in the Leriche-Fontaine functional classification.\n\nExclusion Criteria:\n\n* Patients older than 75 years\n* Hypercoagulable states\n* Cardiac ejection fraction \\< 30%\n* Active vasculopathy in brain, kidneys or heart\n* Neoplastic disease\n* Active infection\n* Diabetic ketoacidosis or hyperosmolar hyperglycemic state\n* Gangrene of the extremity requiring immediate surgery.'}, 'identificationModule': {'nctId': 'NCT00730561', 'briefTitle': 'Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2:A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'Endo01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Hematopoietic stem cell transplantation', 'interventionNames': ['Biological: Hematopoietic stem cell transplantation']}], 'interventions': [{'name': 'Hematopoietic stem cell transplantation', 'type': 'BIOLOGICAL', 'description': 'Intramuscular application of CD34+ hematopoietic stem cells (with a minimum of 2 million CD34+ cells/kg) into the gastrocnemius muscles after stimulation with subcutaneous filgrastim 600 micrograms/kilogram a day for 4 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Universitario "José E. González"', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'overallOfficials': [{'name': 'Fernando J Lavalle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departamento de Endocrinología del Hospital Universitario "José E. González"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Fernando Javier Lavalle Gonzalez', 'oldOrganization': 'Departamento de Endocrinologia'}}}}