Combined delivery of bone marrow-derived mononuclear cells in chronic ischemic heart disease: rationale and study design.
Détails
ID Serval
serval:BIB_3186ABE41A9D
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Combined delivery of bone marrow-derived mononuclear cells in chronic ischemic heart disease: rationale and study design.
Périodique
Clinical cardiology
ISSN
1932-8737 (Electronic)
ISSN-L
0160-9289
Statut éditorial
Publié
Date de publication
08/2013
Peer-reviewed
Oui
Volume
36
Numéro
8
Pages
435-441
Langue
anglais
Notes
Publication types: Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Résumé
Treatment with bone marrow-derived mononuclear cells (BM-MNC) may improve left ventricular (LV) function in patients with chronic ischemic heart disease (IHD). Delivery method of the cell product may be crucial for efficacy.
We aimed to demonstrate that the combination of intramyocardial and intracoronary injection of BM-MNC is safe and improves LV function in patients with chronic IHD.
After a safety/feasibility phase of 10 patients, 54 patients will be randomly assigned in a 1:1:1 pattern to 1 control and 2 BM-MNC treatment groups. The control group will be treated with state-of-the-art medical management. The treatment groups will receive either exclusively intramyocardial injection or a combination of intramyocardial and intracoronary injection of autologous BM-MNC. Left ventricular function as well as scar size, transmural extension, and regional wall-motion score will be assessed by cardiac magnetic resonance imaging studies at baseline and after 6 months. The primary endpoint is the change in global LV ejection fraction by cardiac magnetic resonance from 6 months to baseline.
The results, it is hoped, will have important clinical impact and provide essential information to improve the design of future regenerative-medicine protocols in cardiology.
As cell delivery may play an important role in chronic IHD, we aim to demonstrate feasibility and efficacy of a combined cell-delivery approach in patients with decreased LV function.
We aimed to demonstrate that the combination of intramyocardial and intracoronary injection of BM-MNC is safe and improves LV function in patients with chronic IHD.
After a safety/feasibility phase of 10 patients, 54 patients will be randomly assigned in a 1:1:1 pattern to 1 control and 2 BM-MNC treatment groups. The control group will be treated with state-of-the-art medical management. The treatment groups will receive either exclusively intramyocardial injection or a combination of intramyocardial and intracoronary injection of autologous BM-MNC. Left ventricular function as well as scar size, transmural extension, and regional wall-motion score will be assessed by cardiac magnetic resonance imaging studies at baseline and after 6 months. The primary endpoint is the change in global LV ejection fraction by cardiac magnetic resonance from 6 months to baseline.
The results, it is hoped, will have important clinical impact and provide essential information to improve the design of future regenerative-medicine protocols in cardiology.
As cell delivery may play an important role in chronic IHD, we aim to demonstrate feasibility and efficacy of a combined cell-delivery approach in patients with decreased LV function.
Mots-clé
Bone Marrow Transplantation/methods, Chronic Disease, Clinical Protocols, Feasibility Studies, Humans, Injections, Leukocytes, Mononuclear/transplantation, Magnetic Resonance Imaging, Myocardial Contraction, Myocardial Ischemia/diagnosis, Myocardial Ischemia/physiopathology, Myocardial Ischemia/surgery, Myocardium/pathology, Recovery of Function, Research Design, Stroke Volume, Switzerland, Time Factors, Treatment Outcome, Ventricular Function, Left
Pubmed
Web of science
Open Access
Oui
Création de la notice
15/11/2017 17:03
Dernière modification de la notice
23/02/2024 15:02