Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT00488020
Status:
UNKNOWN
Last Update Posted:
2008-06-13
First Post:
2007-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cells for Treating Critical Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2010-10-21', 'releaseDate': '2010-09-29'}, {'resetDate': '2011-09-28', 'releaseDate': '2011-08-25'}, {'resetDate': '2013-09-17', 'releaseDate': '2013-08-02'}], 'estimatedResultsFirstSubmitDate': '2010-09-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2007-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-06-12', 'studyFirstSubmitDate': '2007-06-15', 'studyFirstSubmitQcDate': '2007-06-18', 'lastUpdatePostDateStruct': {'date': '2008-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suppress pain and heal ischemic ulcers', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'improve quality of life', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rest pain', 'ischemic ulcers'], 'conditions': ['Critical Limb Ischemia', 'Ischemic Ulcers']}, 'descriptionModule': {'briefSummary': 'Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots', 'detailedDescription': 'About 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.This procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Fontaine's classification grade 3 and 4 patients\n\nExclusion Criteria:\n\n* Record of cancer in the last 5 years\n* Over 80 years\n* Diabetic retinopathy"}, 'identificationModule': {'nctId': 'NCT00488020', 'briefTitle': 'Stem Cells for Treating Critical Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Molestias Cardiovasculares'}, 'officialTitle': 'the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia', 'orgStudyIdInfo': {'id': 'imc1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'stem cells transplant', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15015-210', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Jose D Araujo, MD', 'role': 'CONTACT', 'email': 'imc.terapia.celular@terra.com br', 'phone': '551732034000', 'phoneExt': '112'}], 'facility': 'Instituto de Molestias Cardiovasculares', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}], 'centralContacts': [{'name': 'Jose D Araújo, MD', 'role': 'CONTACT', 'email': 'imc.terapia.celular@terra.com.br', 'phone': '551732034000'}], 'overallOfficials': [{'name': 'Jose D Araújo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Molestias Cardiovasculares'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Molestias Cardiovasculares', 'class': 'OTHER'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2010-09-29', 'type': 'RELEASE'}, {'date': '2010-10-21', 'type': 'RESET'}, {'date': '2011-08-25', 'type': 'RELEASE'}, {'date': '2011-09-28', 'type': 'RESET'}, {'date': '2013-08-02', 'type': 'RELEASE'}, {'date': '2013-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Instituto de Molestias Cardiovasculares'}}}}