Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial.

Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Research Abstract Details 

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Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Abstract Text:

Douglas W Losordo,Richard A Schatz,Christopher J White,James E Udelson,Vimal Veereshwarayya,Michelle Durgin,Kian Keong Poh,Robert Weinstein,Marianne Kearney,Muqtada Chaudhry,Aaron Burg,Liz Eaton,Lindsay Heyd,Tina Thorne,Leon Shturman,Peter Hoffmeister,Ken Story,Victor Zak,Douglas Dowling,Jay H Traverse,Rachel E Olson,Janice Flanagan,Donata Sodano,Toshinori Murayama,Atsuhiko Kawamoto,Kengo Fukushima Kusano,Jill Wollins,Frederick Welt,Pinak Shah,Peter Soukas,Takayuki Asahara,Timothy D Henry,

BACKGROUND: A growing population of patients with coronary artery disease experiences angina that is not amenable to revascularization and is refractory to medical therapy. Preclinical studies have indicated that human CD34+ stem cells induce neovascularization in ischemic myocardium, which enhances perfusion and function. METHODS AND RESULTS: Twenty-four patients (19 men and 5 women aged 48 to 84 years) with Canadian Cardiovascular Society class 3 or 4 angina who were undergoing optimal medical treatment and who were not candidates for mechanical revascularization were enrolled in a double-blind, randomized (3:1), placebo-controlled dose-escalating study. Patients received granulocyte colony-stimulating factor 5 microg x kg(-1) x d(-1) for 5 days with leukapheresis on the fifth day. Selection of CD34+ cells was performed with a Food and Drug Administration-approved device. Electromechanical mapping was performed to identify ischemic but viable regions of myocardium for injection of cells (versus saline). The total dose of cells was distributed in 10 intramyocardial, transendocardial injections. Patients were required to have an implantable cardioverter-defibrillator or to temporarily wear a LifeVest wearable defibrillator. No incidence was observed of myocardial infarction induced by mobilization or intramyocardial injection. The intramyocardial injection of cells or saline did not result in cardiac enzyme elevation, perforation, or pericardial effusion. No incidence of ventricular tachycardia or ventricular fibrillation occurred during the administration of granulocyte colony-stimulating factor or intramyocardial injections. One patient with a history of sudden cardiac death/ventricular tachycardia/ventricular fibrillation had catheter-induced ventricular tachycardia during mapping that required cardioversion. Serious adverse events were evenly distributed. Efficacy parameters including angina frequency, nitroglycerine usage, exercise time, and Canadian Cardiovascular Society class showed trends that favored CD34+ cell-treated patients versus control subjects given placebo. CONCLUSIONS: A randomized trial of intramyocardial injection of autologous CD34+ cells in patients with intractable angina was completed that provides evidence for feasibility, safety, and bioactivity. A larger phase IIb study is currently under way to further evaluate this therapy.

Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Publishing Authors By Initials

DW Losordo,RA Schatz,CJ White,JE Udelson,V Veereshwarayya,M Durgin,KK Poh,R Weinstein,M Kearney,M Chaudhry,A Burg,L Eaton,L Heyd,T Thorne,L Shturman,P Hoffmeister,K Story,V Zak,D Dowling,JH Traverse,RE Olson,J Flanagan,D Sodano,T Murayama,A Kawamoto,KF Kusano,J Wollins,F Welt,P Shah,P Soukas,T Asahara,TD Henry,

For similar diagnosis: prognosis: treatment outcome research abstracts see: diagnosis: prognosis: treatment outcome research

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Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: Circulation

VOLUME: 115

Page Numbers: 3165-72

Journal Abbreviation: Circulation

ISSN: 1524-4539

DAY: 11

MONTH: 06

YEAR: 2007

Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 147763

Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Keywords Mesh Terms:

KEYWORDS: Treatment Outcome

MESH TERMS: methods

Chemical & Substance for Abstract: Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Information

Substance Name: Granulocyte Colony-Stimulating Factor

Registry Number: 143011-72-7

Grant and Affiliation Information for Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial.

AFFILIATION: Feinberg Cardiovascular Research Institute, and Department of Medicine, Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital, Chicago, IL 60611, USA. d-losordo@northwestern.edu

Country: United States

AGENCY: United States NHLBI

GRANT: P01HL-66957

ACRONYM: HL

MEDLINETA: Circulation

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