Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-25 @ 4:45 AM
Study NCT ID:
NCT02445534
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2015-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Cell Therapy in Non-Ischemic 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2015-05-12', 'studyFirstSubmitQcDate': '2015-05-14', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in exercise capacity', 'timeFrame': '5 years'}, {'measure': 'Changes in NT-proBNP', 'timeFrame': '5 years'}], 'primaryOutcomes': [{'measure': 'Transplantation-free survival', 'timeFrame': '5 years', 'description': 'Survival after 5 years without undergoing heart transplantation'}], 'secondaryOutcomes': [{'measure': 'Changes in left ventricular ejection fraction', 'timeFrame': '5 years'}, {'measure': 'Changes in left ventricular dimensions', 'timeFrame': '5 years'}, {'measure': 'Changes in left ventricular diastolic function', 'timeFrame': '5 years'}, {'measure': 'Changes in right ventricular function', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cell Therapy'], 'conditions': ['Cardiomyopathy, Dilated']}, 'referencesModule': {'references': [{'pmid': '33012343', 'type': 'DERIVED', 'citation': 'Frljak S, Poglajen G, Zemljic G, Cerar A, Haddad F, Terzic A, Vrtovec B. Larger End-Diastolic Volume Associates With Response to Cell Therapy in Patients With Nonischemic Dilated Cardiomyopathy. Mayo Clin Proc. 2020 Oct;95(10):2125-2133. doi: 10.1016/j.mayocp.2020.02.031.'}, {'pmid': '28296283', 'type': 'DERIVED', 'citation': 'Bervar M, Kozelj M, Poglajen G, Sever M, Zemljic G, Frljak S, Cukjati M, Cernelc P, Haddad F, Vrtovec B. Effects of Transendocardial CD34+ Cell Transplantation on Diastolic Parameters in Patients with Nonischemic Dilated Cardiomyopathy. Stem Cells Transl Med. 2017 Jun;6(6):1515-1521. doi: 10.1002/sctm.16-0331. Epub 2017 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'Although several studies have demonstrated beneficial effects of stem cell therapy in patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of response to therapy remain undefined. The aim of this registry is to pool long-term clinical data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy in an attempt to better define predictors of response to such treatment.', 'detailedDescription': 'Registry will include all patients who underwent intracoronary or intramyocardial cell therapy as a part of clinical trials performed at UMC Ljubljana from January 2005 until January 2018. Patients will be followed on regular basis in a dedicated heart failure outpatient clinic, clinical data will be collected and stored in a secure central database. Data will be analyzed in periodic intervals by an independent Data monitoring board in an attempt to better define the predictors of clinical response to cell therapy in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients enrolled in clinical trials of stem cell therapy in non-ischemic dilated cardiomyopathy at UMC Ljubljana from January, 2005 will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient inclusion criteria consisted of the following: age 18-65 years old, diagnosis of DCM according to the European Society of Cardiology position statement (9), optimal medical management for at least 6 months, left ventricular ejection fraction (LVEF) \\<40%, and New York Heart Association functional Class III on stable medical therapy for at least 3 months before referral.\n\nExclusion Criteria:\n\n* Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.'}, 'identificationModule': {'nctId': 'NCT02445534', 'acronym': 'RECORD', 'briefTitle': 'Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy', 'orgStudyIdInfo': {'id': 'RECORD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Autologous stem cell therapy', 'type': 'BIOLOGICAL', 'description': 'All patients received granulocyte-colony stimulating factor (G-CSF; 5 mg/kg, 5 days). CD34+ cell were then collected by apheresis and injected transendocardially or intracororonary.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Bojan Vrtovec, MD, PhD', 'role': 'CONTACT', 'email': 'bojan.vrtovec@gmail.com', 'phone': '+3861 522 1157'}, {'name': 'Gregor Poglajen, MD, PhD', 'role': 'CONTACT', 'email': 'gregor.poglajen@gmail.com', 'phone': '+3861 522 1148'}], 'facility': 'UMC Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Bojan Vrtovec, MD, PhD', 'role': 'CONTACT', 'email': 'bojan.vrtovec@gmail.com', 'phone': '+3861 522 1157'}, {'name': 'Gregor Poglajen, MD, PhD', 'role': 'CONTACT', 'email': 'gregor.poglajen@gmail.com', 'phone': '+3861 522 1148'}], 'overallOfficials': [{'name': 'Bojan Vrtovec, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Ljubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Advanced Heart Failure and Transplantation Center', 'investigatorFullName': 'Bojan Vrtovec', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}