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| Name | Class |
|---|---|
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
| University College London Hospitals | OTHER |
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A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary injection of progenitor cells compared to placebo injection in patients with Dilated Cardiomyopathy who have been pre-treated with G-CSF (Granocyteâ„¢) injections for 5 days, and patients treated with a 5 day course of G-CSF (Granocyteâ„¢) injection only compared to placebo injection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral | Experimental | Half the patients will be randomised to the non-interventional part of the trial. In this subgroup of patients will be randomised 1:1 to 5 day course of subcutaneous placebo injections or a 5 day course of G-CSF(Granocyteâ„¢) subcutaneous injections |
|
| Interventional arm | Experimental | In the subgroup of the interventional arm patients will be randomised 1:1 to receive a 5 day course of subcutaneous G-CSF (Granocyteâ„¢) injections and bone marrow aspiration at day 5, they will then receive either stem cells or placebo via intracoronary injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| granulocyte colony stimulating factor (GCSF) | Drug | 10mcg/kg per day 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction as measured by cardiac magnetic resonance imaging or computerised tomography | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in: Concentrations of N-terminal prohormone of brain natriuretic peptide (cardiac enzyme) | 3 months and 12 months | |
| Changes in V02 max (exercise capacity) | 3 months and 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Mathur, MD FRCP FESC | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Chest Hospital | London | E2 9JX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21749209 | Background | Arnous S, Mozid A, Mathur A. The Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy (REGENERATE-DCM) trial: study design. Regen Med. 2011 Jul;6(4):525-33. doi: 10.2217/rme.11.29. |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000078224 | Lenograstim |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| bone marrow mononuclear cells | Procedure | intra coronary injection of stem cells or placebo |
|
| Changes in left ventricular ejection fraction, ventricular dimensions as measured by cardiac magnetic resonance imaging or computerised tomography |
| 3 months and 12 months |
| Functional class changes according to NYHA and quality of life (QoL - EQ-5D & Kansas City) questionnaires | 3 months and 12 months |
| Occurrence of a Major Adverse Cardiac Event (MACE) defined as cardiac death, myocardial infarction (CK / CK-MB over 2 times the upper limit of normal) | 3 months and 12 months |
| Hospitalization for Heart failure & the occurrence of major arrhythmias defined as symptomatic ventricular tachycardia or survived sudden death | 3 months and 12 months |
| The occurrence of major arrhythmias defined by symptomatic ventricular tachycardia or survived sudden death | 3 months and 12 months |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |