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Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure (REGEN-IHD)

8. oktober 2013 opdateret af: Anthony Mathur, Barts & The London NHS Trust

Randomised Control Trial to Compare the Effects of G-CSF and Autologous Bone Marrow Progenitor Cells Infusion on the Quality of Life and Left Ventricular Function in Patients With Heart Failure Secondary to Ischaemic Heart Disease

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 method of delivery of these cells.

Study hypotheses:

  • Administration of G-CSF to patients with heart failure secondary to ischaemic heart disease will lead to an increase in circulating progenitor cells as measured by peripheral CD34+ positive cell counts
  • Cardiac function and symptoms will improve in patients in whom the peripheral CD34+ counts increase in response to G-CSF administration
  • Direct coronary injection of autologous bone marrow derived stem cells will confer an additional improvement in cardiac function and symptoms above that derived from G-CSF infusion alone
  • Direct intramyocardial injection of autologous bone marrow derived stem cells will lead to an improvement in cardiac function and symptoms above that derived from G-CSF infusion alone

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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 injection (peripheral arm that injects GCSF alone) or serum (the two interventional arms-intracoronary and intramyocardial injection).

The protocol (on the advice of the ethics committee) is divided into a 58 patients pilot study followed by recruitment into the intramyocardial arm (30 patients randomised 1:1 cells in serum vs serum alone) and then recruitment into the intracoronary and peripheral arms (30 patients randomised 1:1 cells in serum vs serum alone in each arm).

The study has been powered around the use of advanced imaging to measure within group changes in ejection fraction at 12 months as the primary end point.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

148

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, E2 9JX
        • London Chest Hospital, Barts and The London NHS Trust

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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 Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Peripheral
Patients are randomised in a 1:1 ratio to receive granulocyte-colony stimulating factor (G-CSF) or placebo injection
Medicin: Granulocyte-colony stimulating factor
5 days subcutaneous injection
Andre navne:
  • G-CSF
Eksperimentel: Percutaneous intracoronary injection
All patients will receive granulocyte-colony stimulating factor injections followed by a bone marrow aspiration. Patients will be randomised in a 1:1 ratio to receive intracoronary injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route
Medicin: Granulocyte-colony stimulating factor
5 days subcutaneous injection
Andre navne:
  • G-CSF
Procedure: Percutaneous intracoronary injection
Bone marrow derived stem/progenitor cells or placebo infusion is delivered through an over-the-wire balloon catheter into the target coronary vessels using a stop-flow technique.
Eksperimentel: Percutaneous intramyocardial injection
All patients will receive granulocyte-colony stimulating factor injections followed by a bone marrow aspiration. Patients will be randomised in a 1:1 ratio to receive intramyocardial injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route
Medicin: Granulocyte-colony stimulating factor
5 days subcutaneous injection
Andre navne:
  • G-CSF
Procedure: Percutaneous intramyocardial injection
Direct intramyocardial injections of bone marrow derived stem/progenitor cells or placebo will be delivered using the electromechanical NOGA mapping and injection system

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in global left ventricular ejection fraction
Tidsramme: 12 months
12 months

Sekundære resultatmål

Resultatmål
Tidsramme
Change in quality of life
Tidsramme: 6 months
6 months
Occurence of major adverse cardiac event
Tidsramme: 12 months
12 months
Change in quality of life
Tidsramme: 12 months
12 months
Change in NT-proBNP
Tidsramme: 6 months
6 months
change in NYHA class
Tidsramme: 12 months
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Barts & The London NHS Trust

Efterforskere

  • Ledende efterforsker: Anthony Mathur, FRCP FESC Ph, Barts and the London NHS Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2005

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

4. september 2008

Først indsendt, der opfyldte QC-kriterier

4. september 2008

Først opslået (Skøn)

5. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 04/Q0603/13
  • 2005-002706-27 (EudraCT)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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