Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy

Brief Title

Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy

Official Title

Randomised Controlled Trial to Compare the Effects of G-CSF (Granocyte™) and Autologous Bone Marrow Progenitor Cells on Quality of Life and Left Ventricular Function in Patients With Idiopathic Dilated Cardiomyopathy

Brief Summary

      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 (Granocyte™) injections for 5 days, and
      patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo
      injection
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Change in left ventricular ejection fraction as measured by cardiac magnetic resonance imaging or computerised tomography

Secondary Outcome

 Change in: Concentrations of N-terminal prohormone of brain natriuretic peptide (cardiac enzyme)

Condition

Dilated Cardiomyopathy

Intervention

granulocyte colony stimulating factor (GCSF)

Study Arms / Comparison Groups

 Peripheral

Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

60

Start Date

August 2010

Completion Date

July 2013

Primary Completion Date

December 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Symptomatic patients with a confirmed diagnosis of dilated cardiomyopathy (NYHA
             II-III) attending their local 'Heart Failure clinic' who are on optimal heart failure
             treatment, under supervision from their physician or heart failure nurse specialist,
             and have no other treatment options

          -  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:

          -  NYHA I

          -  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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Anthony Mathur, MD FRCP FESC, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

NCT ID

NCT01302171

Organization ID

2009-013112-12

Responsible Party

Principal Investigator

Study Sponsor

Barts & The London NHS Trust

Collaborators

 Royal Brompton & Harefield NHS Foundation Trust

Study Sponsor

Anthony Mathur, MD FRCP FESC, Principal Investigator, Barts & The London NHS Trust

Verification Date

November 2013