Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy
NCT ID: NCT01302171
Last Updated: 2013-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-08-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Peripheral
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(Granocyte™) subcutaneous injections
granulocyte colony stimulating factor (GCSF)
10mcg/kg per day 5 days
Interventional arm
In the subgroup of the interventional arm patients will be randomised 1:1 to receive a 5 day course of subcutaneous G-CSF (Granocyte™) injections and bone marrow aspiration at day 5, they will then receive either stem cells or placebo via intracoronary injection
bone marrow mononuclear cells
intra coronary injection of stem cells or placebo
Interventions
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granulocyte colony stimulating factor (GCSF)
10mcg/kg per day 5 days
bone marrow mononuclear cells
intra coronary injection of stem cells or placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who are NYHA II that have been hospitalised with a dilated cardiomyopathy related condition
* Coronary angiography will be performed where necessary to confirm the diagnosis and ensure no other conventional treatment options are indicated
* Prior to recruitment to the study patients at risk of ventricular arrhythmia will have undergone electrophysiological assessment and appropriate clinical management (including implantable defibrillator insertion) where indicated (as per NICE guidelines)
Exclusion Criteria
* Referral hospitals most recent documented ejection fraction of \>45% (any imaging modality)
* The presence of cardiogenic shock
* The presence of acute left and/or right sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
* Known severe pre-existent left ventricular dysfunction (with a documented ejection fraction of \<10% from referral hospital) prior to randomisation
* Congenital cardiac disease
* Cardiomyopathy secondary to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia
* Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
* Previous cardiac surgery
* Contra-indication for bone marrow aspiration
* Known active infection
* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), HTLV or syphilis.
* Chronic inflammatory disease requiring ongoing medication
* Serious known concomitant disease with a life expectancy of less than one year
* Follow-up impossible (no fixed abode, etc)
* Patients with an irregular heart rhythm (AF allowed if paced in a regular rhythm)
* Patients with renal impairment (Creatinine \>200mmol/L)
* Neoplastic disease without documented remission within the past 5 years
* Weight\>140kg
* Subjects of childbearing potential
18 Years
80 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
University College London Hospitals
OTHER
Barts & The London NHS Trust
OTHER
Responsible Party
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Anthony Mathur
Clinical and Research Lead (Cardiology)
Principal Investigators
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Anthony Mathur, MD FRCP FESC
Role: PRINCIPAL_INVESTIGATOR
Barts & The London NHS Trust
Locations
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London Chest Hospital
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2009-013112-12
Identifier Type: -
Identifier Source: org_study_id