Status:
COMPLETED
Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure
Lead Sponsor:
Barts & The London NHS Trust
Conditions:
Chronic Ischaemic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether adult bone marrow derived stem/progenitor cells improve cardiac function and symptoms in patients with heart failure and to establish the optimal meth...
Detailed Description
The study involves three arms that compare the method of autologous bone marrow cel administration in patients with chronic heart failure. Each arm has a comparative group that contains either saline ...
Eligibility Criteria
Inclusion
- Symptomatic patients with a diagnosis of heart failure secondary to ischaemic heart disease who are on optimal heart failure treatment and no further treatment options available
- Patient has been considered for an implantable defibrillator in keeping with NICE guidelines
Exclusion
- Recent acute coronary syndrome as judged by a rise of Troponin above normal values in the last 6 months
- 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 (ejection fraction \< 10% prior to randomisation)
- Congenital cardiac disease
- Cardiomyopathy secondary to a reversible cause 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
- Contra-indication for bone marrow aspiration
- Known active infection
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) syphilis or HTLV
- Lifestyle with high risk for infection with HIV, HBV or HCV syphilis or HTLV
- Serum creatinine \>200 umol/L
- Chronic inflammatory disease
- Serious known concomitant disease with a life expectancy of less than one year
- Follow-up impossible (no fixed abode, etc)
- Previous participation in this study
- Female subjects of childbearing potential
- Atrial fibrillation
- Patients who have responded to the implantation of a biventricular pacemaker
- Weight \>140kg
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00747708
Start Date
August 1 2005
End Date
May 1 2013
Last Update
October 9 2013
Active Locations (1)
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1
London Chest Hospital, Barts and the London NHS Trust
London, London, United Kingdom, E2 9JX