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OpenTrials
Completed

NCT Number: NCT01302171

Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Chest Hospital

London, E2 9JX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

granulocyte colony stimulating factor (GCSF)

Drug

10mcg/kg per day 5 days

Other names: Lenograstim, Granocyte™, Chugai Pharma UK, Limited

bone marrow mononuclear cells

Procedure

intra coronary injection of stem cells or placebo

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months and 12 months

  2. Changes in V02 max (exercise capacity)

    Time frame: 3 months and 12 months

  3. Changes in left ventricular ejection fraction, ventricular dimensions as measured by cardiac magnetic resonance imaging or computerised tomography

    Time frame: 3 months and 12 months

  4. Functional class changes according to NYHA and quality of life (QoL - EQ-5D & Kansas City) questionnaires

    Time frame: 3 months and 12 months

  5. 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)

    Time frame: 3 months and 12 months

  6. Hospitalization for Heart failure & the occurrence of major arrhythmias defined as symptomatic ventricular tachycardia or survived sudden death

    Time frame: 3 months and 12 months

  7. The occurrence of major arrhythmias defined by symptomatic ventricular tachycardia or survived sudden death

    Time frame: 3 months and 12 months

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust
  • University College London Hospitals

Registry information

Official study 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

Acronym: REGEN-DCM

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Feb 24, 2011
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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