Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT01449032
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2011-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-07', 'studyFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise test', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Clinical evaluation', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Patients'], 'conditions': ['Chronic Ischemic Heart Disease']}, 'referencesModule': {'references': [{'pmid': '31711513', 'type': 'DERIVED', 'citation': 'Qayyum AA, Mathiasen AB, Helqvist S, Jorgensen E, Haack-Sorensen M, Ekblond A, Kastrup J. Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial): 3-years follow-up results. J Transl Med. 2019 Nov 12;17(1):360. doi: 10.1186/s12967-019-2110-1.'}, {'pmid': '29333165', 'type': 'DERIVED', 'citation': 'Qayyum AA, Mathiasen AB, Mygind ND, Kuhl JT, Jorgensen E, Helqvist S, Elberg JJ, Kofoed KF, Vejlstrup NG, Fischer-Nielsen A, Haack-Sorensen M, Ekblond A, Kastrup J. Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study. Stem Cells Int. 2017;2017:5237063. doi: 10.1155/2017/5237063. Epub 2017 Dec 3.'}]}, 'descriptionModule': {'briefSummary': "Coronary artery disease (CAD) is the most common cause of death and a major cause of hospital admissions for acute chest pain. In spite of improved treatments still many patients with CAD have daily attacks of severe chest pain and severely reduced life quality.\n\nThe investigators have established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with adipose derived stem cells to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.", 'detailedDescription': "In an open single centre pilot study we have evaluated the safety and efficacy of MSC treatment to improve heart muscle perfusion in patients with chronic CAD. Patients treated with MSCs had significant increased exercise capacity, reduction in angina, angina attacks and medication and in life quality at 6 months follow-up. For all the parameters there was a tendency towards improved outcome with increasing number of cells. The treatment with MSCs was safe.\n\nThe investigators have now established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with MSCs to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CCS III - IV\n* Coronary artery stenosis/occlusion not treatable with invasive procedures\n* LVEF \\> 40%\n* ETT between 2 - 10 min\n\nExclusion Criteria:\n\n* Valvular heart disease\n* FEV1 \\< 1\n* Severe systemic disease\n* Acute coronary syndrome \\> 2 months'}, 'identificationModule': {'nctId': 'NCT01449032', 'acronym': 'MyStromalCell', 'briefTitle': 'MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)', 'orgStudyIdInfo': {'id': 'MyStromalCell'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MSC', 'description': 'Adipose derived stem cells', 'interventionNames': ['Biological: MSC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Biological: Saline']}], 'interventions': [{'name': 'MSC', 'type': 'BIOLOGICAL', 'otherNames': ['Adipose derived stem cells', 'Mesenchymal stromal cells', 'Mesenchymal stem cells'], 'description': 'No of cells after culture expansion', 'armGroupLabels': ['MSC']}, {'name': 'Saline', 'type': 'BIOLOGICAL', 'description': '3 cc saline', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet University Hospital Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jens Kastrup, MD Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'JKastrup', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}