Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT01504594
Status:
SUSPENDED
Last Update Posted:
2013-08-09
First Post:
2011-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'whyStopped': 'Suspended because the lack of patients among the time this clinical trial was running.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2012-01-04', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safeness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.', 'timeFrame': '6 weeks', 'description': 'Patient will be assessed to prove that the procedure did not cause any deterioration of his/her health presented at the beginning of the study.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of autologous bone marrow derived stem cells infused through cardiac catheterization to coronary arteries.', 'timeFrame': '6 months', 'description': 'Patient will be assessed to measure and record any possible changes in his/her clinical and echocardiographic studies that will reflect improvement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dilated cardiomyopathy', 'Idiopathic', 'Bone Marrow', 'Stem Cells', 'CD34 +', 'Autologous'], 'conditions': ['Cardiomyopathy, Dilated']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.medicina.uanl.mx/hu/', 'label': 'University Hospital Dr. Jose E. Gonzalez'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an autologous stem cell infusion through catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy.\n\nProcess:\n\n1. Primary Evaluation\n\n * Clinical History\n * Echocardiogram to evaluate ejection fraction and other parameters\n2. Signing of Informed Consent and clearing doubts\n3. Bone Marrow stimulation for 3 consecutive days with G-CSF (Granulocyte Colony Stimulating Factor) applied subcutaneously\n4. On the 4th day, in operation room and under sedation: Bone Marrow Harvest performed by hematologists through posterior iliac crests(amount calculated at 8cc/kg, without exceeding 150ml).\n5. Recovery room with family members while the cells are being processed in the Hematology Laboratory.\n6. Approximately 3 hours after the 1st procedure, the patient re-enters the operation room, which is equipped for cardiac catheterization, so that cardiologists infuse the stem cells through the femoral artery into the coronary arteries which irrigate the heart´s muscle fibers.\n7. Patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids.\n8. Clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.', 'detailedDescription': '* The Patient will receive standard surgical care, accompanied by a nurse at all times.\n* Premedication includes: Omeprazole (gastric protector), Ketorolac (anti-pain and swelling), ondansetron (antivomiting).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ejection fraction less than 35 percent in echocardiogram\n* More than 3 months with complete medical treatment without significant improvement\n* Complete medical treatment: digitalics, diuretics, vasodilators and beta blockers\n\nExclusion Criteria:\n\n* Not signing informed consent\n* Active infection at enrolling time\n* Inadequate G-CSF application'}, 'identificationModule': {'nctId': 'NCT01504594', 'briefTitle': 'Autologous Stem Cells in Pediatric Patients With Dilated Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'Safeness and Effectiveness of Autologous Hematopoietic Cell Infusion Through Catheterization in Pediatric Patients With Dilated Cardiomyopathy', 'orgStudyIdInfo': {'id': 'HE-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'Children which meet eligibility criteria and after being assessed, are stimulated with G-CSF, undergo bone marrow extraction and then have them applied directly to the coronary arteries through cardiac catheterization.', 'interventionNames': ['Procedure: Intracoronary autologous stem cell infusion']}], 'interventions': [{'name': 'Intracoronary autologous stem cell infusion', 'type': 'PROCEDURE', 'otherNames': ['Intracoronary CD34+ cell infusion'], 'description': 'Under sedation and under sterile conditions in a fluoroscopy operation room, cardiac catheterization will be performed through the femoral artery to infuse the stem cells directly into the heart´s coronary arteries.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'N.l.', 'country': 'Mexico', 'facility': 'University Hospital Dr. Jose E. Gonzalez', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'overallOfficials': [{'name': 'Consuelo Mancias, Hematologist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hematology Service, University Hospital of Monterrey'}, {'name': 'Gerardo Sanchez, Cardiologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatrics Service, University Hospital of Monterrey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Hematology Professor', 'investigatorFullName': 'Consuelo Mancias Guerra', 'investigatorAffiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}}}}