Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 6:26 PM
Study NCT ID:
NCT03572660
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2018-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm intervention study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in left ventricular ejection fraction', 'timeFrame': 'Baseline to 3 months', 'description': 'Change in left ventricular ejection fraction as measured by cardiac CT'}], 'secondaryOutcomes': [{'measure': 'Change in left ventricular ejection fraction', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in left ventricular ejection fraction as measured by cardiac CT'}, {'measure': 'Change in exercise capacity', 'timeFrame': 'Baseline to 3 and 12 months', 'description': 'Change in exercise capacity as assessed by a 6-minute walk test'}, {'measure': 'Change in heart failure symptoms', 'timeFrame': 'Baseline to 3 and 12 months', 'description': 'Change in heart failure symptoms as measured by NYHA classification'}, {'measure': 'Change in quality of life as assessed by Minnesota Living with Heart Failure Questionnaire scores', 'timeFrame': 'Baseline to 3 and 12 months', 'description': 'Change in quality of life as measured by MLHFQ (The 21-item MLHFQ uses a 6-point Likert scale, where 0 = no, 1= very little and 5= very much. The questions are intended to be representative of the ways heart failure can affect physical and emotional dimensions of quality of life)'}, {'measure': 'Change in quality of life as measured by EuroQol-5 Dimension 5 Levels questionnaires', 'timeFrame': 'Baseline to 3 and 12 months', 'description': 'Change in quality of life as measured by EQ-5D-5L questionnaires (the scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression)'}, {'measure': 'Procedural safety as assessed by in-hospital procedural related morbidity/mortality', 'timeFrame': 'In-hospital procedural time', 'description': 'Procedural safety as assessed by in-hospital procedural related morbidity/mortality'}, {'measure': 'Change in biochemical markers of heart failure', 'timeFrame': 'Baseline to 3 and 12 months', 'description': 'Change in biochemical markers of heart failure as measured by change in NT-proBNP'}, {'measure': 'Assessment of rates of MACE (cumulative & individual components)', 'timeFrame': '3 and 12 months', 'description': 'Rates of MACE (all-cause death, myocardial infarction, hospitalisation for heart failure, major arrhythmias \\[defined as VT and VF\\])'}, {'measure': 'Assessment of rates of stroke', 'timeFrame': '3 and 12 months', 'description': 'Assessment of rates of stroke'}, {'measure': 'Assessment of peri-procedural myocardial infarction', 'timeFrame': 'Day 0 and Day 6', 'description': 'Assessment of peri-procedural myocardial infarction as per SCAI definition measured by change in troponin (MI defined by increase in troponin \\>70 times upper limit of normal from baseline).'}, {'measure': 'Change in renal function', 'timeFrame': 'Baseline to 3 and 12 months', 'description': 'Change in renal function from baseline at 3 and 12 months as measured by creatinine levels.'}, {'measure': 'Change in inflammatory markers', 'timeFrame': 'Baseline to 3 and 12 months', 'description': 'Change in inflammatory markers as measured by change in C-reactive protein'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stem Cell', 'Circulatory Support', 'Heart Failure', 'G-CSF'], 'conditions': ['Dilated Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '40145630', 'type': 'DERIVED', 'citation': 'Fawaz S, Ramaseshan R, Khan S, Davies JR, Collet C, Karamasis GV, Cook CM, Jones DA, Mathur A, Keeble TR. Left Ventricular Unloading in Nonischemic Dilated Cardiomyopathy Improves Coronary Haemodynamic Reserve. Catheter Cardiovasc Interv. 2025 Jun;105(7):1719-1722. doi: 10.1002/ccd.31514. Epub 2025 Mar 27.'}, {'pmid': '37190883', 'type': 'DERIVED', 'citation': 'Reid A, Hussain M, Veerapen J, Ramaseshan R, Hall R, Bowles R, Jones DA, Mathur A. DCM Support: cell therapy and circulatory support for dilated cardiomyopathy patients with severe ventricular impairment. ESC Heart Fail. 2023 Aug;10(4):2664-2671. doi: 10.1002/ehf2.14393. Epub 2023 May 15.'}]}, 'descriptionModule': {'briefSummary': "DCM Support is recruiting patients with dilated cardiomyopathy and heart failure symptoms. The goal of this clinical trial is to examine whether treatment with a patient's own stem cells can improve their heart function and alleviate heart failure symptoms.\n\n* Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic.\n* The stem cells will be infused into the arteries that supply blood to the heart under local anaesthetic.\n* A mini heart pump will be used to take the strain off the heart during the procedure.\n* The follow-up involves a phone call at 1 month and clinic visits at 3 and 12 months", 'detailedDescription': "DCM SUPPORT is a single centre, single arm clinical trial taking place at St Bartholomew's Hospital in London, UK.\n\n* It is recruiting patients with dilated cardiomyopathy and ongoing heart failure symptoms\n* All patients undergo a bone marrow aspiration after 5 days of subcutaneous G-CSF injections\n* After cell processing, bone marrow-derived mononuclear cells are infused into the coronary arteries using the stop-flow technique. An intra-procedural Impella CP device is used to support the circulation.\n* The primary endpoint is change in left ventricular ejection fraction at 3 months as measured by cardiac CT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of dilated cardiomyopathy under the supervision of a physician or a heart failure nurse specialist.\n* NYHA class ≥ 2 symptoms despite having received optimal medical therapy and appropriate device therapy, as per clinical guidelines for an interval of at least 3 months.\n* No other treatment options available as part of the current best standard of care.\n* LVEF ≤35% on any imaging modality performed as part of the screening phase.\n\nExclusion Criteria:\n\n* Congenital heart disease.\n* Clinically significant valvular heart disease.\n* Patients who are not suitable for a Percutaneous Mechanical Support Device (E.g. unsuitable femoral artery anatomy, unable able to lie flat for prolonged time to accommodate the stem cell infusion \\& presence of LV thrombus)\n* Weight of patient that exceeds the maximum limit of the cardiac catheterisation laboratory table / CT scanner.\n* Cardiomyopathy 2o to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \\& chronic uncontrolled tachycardia.\n* Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.\n* Previous cardiac surgery.\n* Contra-indication for bone marrow aspiration (thrombocytopaenia - platelet count \\<80 x 10(9)/L or extensive surgical scarring/anatomical deformity at site of bone marrow puncture).\n* Known active infection on admission as defined by a temperature \\>37.5°C or on a short course of antibiotics.\n* An active infection of hepatitis B, hepatitis C, syphilis or HTLV\n* Known HIV infection\n* Chronic inflammatory disease requiring on-going medication.\n* Concomitant disease with a life expectancy of less than one year\n* Follow-up impossible (no fixed abode, etc.)\n* Neoplastic disease without documented remission within the past 5 years.\n* Patients on renal replacement therapy.\n* Subjects of childbearing potential unless βHCG negative and are on adequate contraception during the trial.\n* Patients falling into the vulnerable category or lacking capacity\n* Patients who are unable to understand or read written English will be excluded from the trial.\n* Killip Class III or above"}, 'identificationModule': {'nctId': 'NCT03572660', 'acronym': 'DCM-Support', 'briefTitle': 'Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'Phase II Study Assessing the Combined Use of Autologous Bone Marrow Derived Mononuclear Cells and G-csf With Percutaneous Circulatory Assistance in the Treatment of Dilated Cardiomyopathy', 'orgStudyIdInfo': {'id': 'Reda 012357'}, 'secondaryIdInfos': [{'id': '2018-001063-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BMMNC intervention arm', 'description': 'Bone marrow derived mononuclear cells and G-CSF', 'interventionNames': ['Biological: Bone marrow derived mononuclear cells and G-CSF']}], 'interventions': [{'name': 'Bone marrow derived mononuclear cells and G-CSF', 'type': 'BIOLOGICAL', 'description': 'Intra-coronary infusion', 'armGroupLabels': ['BMMNC intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1A 7BE', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sonia Bastos', 'role': 'CONTACT', 'email': 's.bastos@nhs.net', 'phone': '0203 765 8704'}, {'name': 'Alice Reid', 'role': 'CONTACT', 'email': 'a.e.reid@qmul.ac.uk'}], 'facility': "St Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Anthony Mathur', 'role': 'CONTACT', 'email': 'a.mathur@qmul.ac.uk', 'phone': '0203 765 8704'}, {'name': 'Sonia Bastos', 'role': 'CONTACT', 'email': 's.bastos@nhs.net', 'phone': '0203 765 8704'}], 'overallOfficials': [{'name': 'Anthony Mathur', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary University of London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}