Phase
Condition
Cardiac Disease
Cardiomyopathy
Heart Disease
Treatment
Bone marrow derived mononuclear cells and G-CSF
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with a confirmed diagnosis of dilated cardiomyopathy under the supervisionof a physician or a heart failure nurse specialist.
NYHA class ≥ 2 symptoms despite having received optimal medical therapy andappropriate device therapy, as per clinical guidelines for an interval of at least 3months.
No other treatment options available as part of the current best standard of care.
LVEF ≤35% on any imaging modality performed as part of the screening phase.
Exclusion
Exclusion Criteria:
Congenital heart disease.
Clinically significant valvular heart disease.
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 toaccommodate the stem cell infusion & presence of LV thrombus)
Weight of patient that exceeds the maximum limit of the cardiac catheterisationlaboratory table / CT scanner.
Cardiomyopathy 2o to a reversible cause that has not been treated e.g. thyroiddisease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, seleniumtoxicity & chronic uncontrolled tachycardia.
Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne'sprogressive muscular dystrophy.
Previous cardiac surgery.
Contra-indication for bone marrow aspiration (thrombocytopaenia - platelet count <80x 10(9)/L or extensive surgical scarring/anatomical deformity at site of bone marrowpuncture).
Known active infection on admission as defined by a temperature >37.5°C or on ashort course of antibiotics.
An active infection of hepatitis B, hepatitis C, syphilis or HTLV
Known HIV infection
Chronic inflammatory disease requiring on-going medication.
Concomitant disease with a life expectancy of less than one year
Follow-up impossible (no fixed abode, etc.)
Neoplastic disease without documented remission within the past 5 years.
Patients on renal replacement therapy.
Subjects of childbearing potential unless βHCG negative and are on adequatecontraception during the trial.
Patients falling into the vulnerable category or lacking capacity
Patients who are unable to understand or read written English will be excluded fromthe trial.
Killip Class III or above
Study Design
Study Description
Connect with a study center
St Bartholomew's Hospital
London, EC1A 7BE
United KingdomSite Not Available
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