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Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial

Summary Background c-kit-positive, lineage-negative cardiac stem cells (CSCs) improve post-infarction left ventricular (LV) dysfunction when administered to animals. We undertook a phase 1 trial (Stem Cell Infusion in Patients with Ischemic cardiOmyopathy [SCIPIO]) of autologous CSCs for the treatme... Full description

Journal Title: The Lancet (British edition) 2011, Vol.378 (9806), p.1847-1857
Main Author: Bolli, Roberto, Prof
Other Authors: Chugh, Atul R, MD , D'Amario, Domenico, MD , Loughran, John H, MD , Stoddard, Marcus F, Prof , Ikram, Sohail, Prof , Beache, Garth M, MD , Wagner, Stephen G, MD , Leri, Annarosa, MD , Hosoda, Toru, MD , Sanada, Fumihiro, MD , Elmore, Julius B, MD , Goichberg, Polina, PhD , Cappetta, Donato, PhD , Solankhi, Naresh K, MD , Fahsah, Ibrahim, MD , Rokosh, D Gregg, PhD , Slaughter, Mark S, Prof , Kajstura, Jan, PhD , Anversa, Piero, Prof
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0140-6736
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title: Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial
format: Article
creator:
  • Bolli, Roberto, Prof
  • Chugh, Atul R, MD
  • D'Amario, Domenico, MD
  • Loughran, John H, MD
  • Stoddard, Marcus F, Prof
  • Ikram, Sohail, Prof
  • Beache, Garth M, MD
  • Wagner, Stephen G, MD
  • Leri, Annarosa, MD
  • Hosoda, Toru, MD
  • Sanada, Fumihiro, MD
  • Elmore, Julius B, MD
  • Goichberg, Polina, PhD
  • Cappetta, Donato, PhD
  • Solankhi, Naresh K, MD
  • Fahsah, Ibrahim, MD
  • Rokosh, D Gregg, PhD
  • Slaughter, Mark S, Prof
  • Kajstura, Jan, PhD
  • Anversa, Piero, Prof
subjects:
  • Abridged Index Medicus
  • Autografts
  • Biological and medical sciences
  • c-Kit protein
  • Cardiology
  • Cardiology. Vascular system
  • Cardiomyopathy
  • Cardiovascular disease
  • Care and treatment
  • Combined Modality Therapy
  • Coronary artery
  • Coronary Artery Bypass - methods
  • Coronary artery disease
  • Coronary Vessels
  • Design
  • Diagnosis
  • Echocardiography, Doppler - methods
  • Evidence-based medicine
  • FDA approval
  • Female
  • Follow-Up Studies
  • General aspects
  • Heart
  • Heart attacks
  • Heart cells
  • Heart diseases
  • Heart failure
  • Heart Failure - prevention & control
  • Heart Failure - therapy
  • Heart surgery
  • Humans
  • Injections, Intra-Arterial
  • Internal Medicine
  • Ischemia
  • Laboratories
  • Magnetic resonance imaging
  • Magnetic Resonance Imaging - methods
  • Male
  • Medical sciences
  • Methods
  • Middle Aged
  • Mortality
  • Myocardial infarction
  • Myocardial Infarction - diagnosis
  • Myocardial Infarction - mortality
  • Myocardial Infarction - therapy
  • Myocardial ischemia
  • Myocardial Ischemia - diagnosis
  • Myocardial Ischemia - mortality
  • Myocardial Ischemia - therapy
  • Myocarditis. Cardiomyopathies
  • Myocytes, Cardiac - transplantation
  • Patients
  • Physiological aspects
  • Postoperative Care - methods
  • Prospective Studies
  • Randomization
  • Reference Values
  • Review boards
  • Risk Assessment
  • Stem cell transplantation
  • Stem Cell Transplantation - methods
  • Stem cells
  • Studies
  • Surgery
  • Survival Analysis
  • Time Factors
  • Tissue and Organ Harvesting
  • Transplantation
  • Transplantation, Autologous - methods
  • Treatment Outcome
  • Veins & arteries
  • Ventricle
  • Ventricular Remodeling - physiology
ispartof: The Lancet (British edition), 2011, Vol.378 (9806), p.1847-1857
description: Summary Background c-kit-positive, lineage-negative cardiac stem cells (CSCs) improve post-infarction left ventricular (LV) dysfunction when administered to animals. We undertook a phase 1 trial (Stem Cell Infusion in Patients with Ischemic cardiOmyopathy [SCIPIO]) of autologous CSCs for the treatment of heart failure resulting from ischaemic heart disease. Methods In stage A of the SCIPIO trial, patients with post-infarction LV dysfunction (ejection fraction [EF] ≤40%) before coronary artery bypass grafting were consecutively enrolled in the treatment and control groups. In stage B, patients were randomly assigned to the treatment or control group in a 2:3 ratio by use of a computer-generated block randomisation scheme. 1 million autologous CSCs were administered by intracoronary infusion at a mean of 113 days (SE 4) after surgery; controls were not given any treatment. Although the study was open label, the echocardiographic analyses were masked to group assignment. The primary endpoint was short-term safety of CSCs and the secondary endpoint was efficacy. A per-protocol analysis was used. This study is registered with ClinicalTrials.gov , number NCT00474461. Findings This study is still in progress. 16 patients were assigned to the treatment group and seven to the control group; no CSC-related adverse effects were reported. In 14 CSC-treated patients who were analysed, LVEF increased from 30·3% (SE 1·9) before CSC infusion to 38·5% (2·8) at 4 months after infusion (p=0·001). By contrast, in seven control patients, during the corresponding time interval, LVEF did not change (30·1% [2·4] at 4 months after CABG vs 30·2% [2·5] at 8 months after CABG). Importantly, the salubrious effects of CSCs were even more pronounced at 1 year in eight patients (eg, LVEF increased by 12·3 ejection fraction units [2·1] vs baseline, p=0·0007). In the seven treated patients in whom cardiac MRI could be done, infarct size decreased from 32·6 g (6·3) by 7·8 g (1·7; 24%) at 4 months (p=0·004) and 9·8 g (3·5; 30%) at 1 year (p=0·04). Interpretation These initial results in patients are very encouraging. They suggest that intracoronary infusion of autologous CSCs is effective in improving LV systolic function and reducing infarct size in patients with heart failure after myocardial infarction, and warrant further, larger, phase 2 studies. Funding University of Louisville Research Foundation and National Institutes of Health.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleCardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial
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creatorBolli, Roberto, Prof ; Chugh, Atul R, MD ; D'Amario, Domenico, MD ; Loughran, John H, MD ; Stoddard, Marcus F, Prof ; Ikram, Sohail, Prof ; Beache, Garth M, MD ; Wagner, Stephen G, MD ; Leri, Annarosa, MD ; Hosoda, Toru, MD ; Sanada, Fumihiro, MD ; Elmore, Julius B, MD ; Goichberg, Polina, PhD ; Cappetta, Donato, PhD ; Solankhi, Naresh K, MD ; Fahsah, Ibrahim, MD ; Rokosh, D Gregg, PhD ; Slaughter, Mark S, Prof ; Kajstura, Jan, PhD ; Anversa, Piero, Prof
creatorcontribBolli, Roberto, Prof ; Chugh, Atul R, MD ; D'Amario, Domenico, MD ; Loughran, John H, MD ; Stoddard, Marcus F, Prof ; Ikram, Sohail, Prof ; Beache, Garth M, MD ; Wagner, Stephen G, MD ; Leri, Annarosa, MD ; Hosoda, Toru, MD ; Sanada, Fumihiro, MD ; Elmore, Julius B, MD ; Goichberg, Polina, PhD ; Cappetta, Donato, PhD ; Solankhi, Naresh K, MD ; Fahsah, Ibrahim, MD ; Rokosh, D Gregg, PhD ; Slaughter, Mark S, Prof ; Kajstura, Jan, PhD ; Anversa, Piero, Prof
descriptionSummary Background c-kit-positive, lineage-negative cardiac stem cells (CSCs) improve post-infarction left ventricular (LV) dysfunction when administered to animals. We undertook a phase 1 trial (Stem Cell Infusion in Patients with Ischemic cardiOmyopathy [SCIPIO]) of autologous CSCs for the treatment of heart failure resulting from ischaemic heart disease. Methods In stage A of the SCIPIO trial, patients with post-infarction LV dysfunction (ejection fraction [EF] ≤40%) before coronary artery bypass grafting were consecutively enrolled in the treatment and control groups. In stage B, patients were randomly assigned to the treatment or control group in a 2:3 ratio by use of a computer-generated block randomisation scheme. 1 million autologous CSCs were administered by intracoronary infusion at a mean of 113 days (SE 4) after surgery; controls were not given any treatment. Although the study was open label, the echocardiographic analyses were masked to group assignment. The primary endpoint was short-term safety of CSCs and the secondary endpoint was efficacy. A per-protocol analysis was used. This study is registered with ClinicalTrials.gov , number NCT00474461. Findings This study is still in progress. 16 patients were assigned to the treatment group and seven to the control group; no CSC-related adverse effects were reported. In 14 CSC-treated patients who were analysed, LVEF increased from 30·3% (SE 1·9) before CSC infusion to 38·5% (2·8) at 4 months after infusion (p=0·001). By contrast, in seven control patients, during the corresponding time interval, LVEF did not change (30·1% [2·4] at 4 months after CABG vs 30·2% [2·5] at 8 months after CABG). Importantly, the salubrious effects of CSCs were even more pronounced at 1 year in eight patients (eg, LVEF increased by 12·3 ejection fraction units [2·1] vs baseline, p=0·0007). In the seven treated patients in whom cardiac MRI could be done, infarct size decreased from 32·6 g (6·3) by 7·8 g (1·7; 24%) at 4 months (p=0·004) and 9·8 g (3·5; 30%) at 1 year (p=0·04). Interpretation These initial results in patients are very encouraging. They suggest that intracoronary infusion of autologous CSCs is effective in improving LV systolic function and reducing infarct size in patients with heart failure after myocardial infarction, and warrant further, larger, phase 2 studies. Funding University of Louisville Research Foundation and National Institutes of Health.
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0ISSN: 0140-6736
1EISSN: 1474-547X
2DOI: 10.1016/S0140-6736(11)61590-0
3PMID: 22088800
4CODEN: LANCAO
languageeng
publisherKidlington: Elsevier Ltd
subjectAbridged Index Medicus ; Autografts ; Biological and medical sciences ; c-Kit protein ; Cardiology ; Cardiology. Vascular system ; Cardiomyopathy ; Cardiovascular disease ; Care and treatment ; Combined Modality Therapy ; Coronary artery ; Coronary Artery Bypass - methods ; Coronary artery disease ; Coronary Vessels ; Design ; Diagnosis ; Echocardiography, Doppler - methods ; Evidence-based medicine ; FDA approval ; Female ; Follow-Up Studies ; General aspects ; Heart ; Heart attacks ; Heart cells ; Heart diseases ; Heart failure ; Heart Failure - prevention & control ; Heart Failure - therapy ; Heart surgery ; Humans ; Injections, Intra-Arterial ; Internal Medicine ; Ischemia ; Laboratories ; Magnetic resonance imaging ; Magnetic Resonance Imaging - methods ; Male ; Medical sciences ; Methods ; Middle Aged ; Mortality ; Myocardial infarction ; Myocardial Infarction - diagnosis ; Myocardial Infarction - mortality ; Myocardial Infarction - therapy ; Myocardial ischemia ; Myocardial Ischemia - diagnosis ; Myocardial Ischemia - mortality ; Myocardial Ischemia - therapy ; Myocarditis. Cardiomyopathies ; Myocytes, Cardiac - transplantation ; Patients ; Physiological aspects ; Postoperative Care - methods ; Prospective Studies ; Randomization ; Reference Values ; Review boards ; Risk Assessment ; Stem cell transplantation ; Stem Cell Transplantation - methods ; Stem cells ; Studies ; Surgery ; Survival Analysis ; Time Factors ; Tissue and Organ Harvesting ; Transplantation ; Transplantation, Autologous - methods ; Treatment Outcome ; Veins & arteries ; Ventricle ; Ventricular Remodeling - physiology
ispartofThe Lancet (British edition), 2011, Vol.378 (9806), p.1847-1857
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0Elsevier Ltd
12011 Elsevier Ltd
22015 INIST-CNRS
3Copyright © 2011 Elsevier Ltd. All rights reserved.
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5Copyright Elsevier Limited Nov 26, 2011
6Copyright Elsevier Limited Nov 26-Dec 2, 2011
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1Chugh, Atul R, MD
2D'Amario, Domenico, MD
3Loughran, John H, MD
4Stoddard, Marcus F, Prof
5Ikram, Sohail, Prof
6Beache, Garth M, MD
7Wagner, Stephen G, MD
8Leri, Annarosa, MD
9Hosoda, Toru, MD
10Sanada, Fumihiro, MD
11Elmore, Julius B, MD
12Goichberg, Polina, PhD
13Cappetta, Donato, PhD
14Solankhi, Naresh K, MD
15Fahsah, Ibrahim, MD
16Rokosh, D Gregg, PhD
17Slaughter, Mark S, Prof
18Kajstura, Jan, PhD
19Anversa, Piero, Prof
title
0Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial
1The Lancet (British edition)
addtitleLancet
descriptionSummary Background c-kit-positive, lineage-negative cardiac stem cells (CSCs) improve post-infarction left ventricular (LV) dysfunction when administered to animals. We undertook a phase 1 trial (Stem Cell Infusion in Patients with Ischemic cardiOmyopathy [SCIPIO]) of autologous CSCs for the treatment of heart failure resulting from ischaemic heart disease. Methods In stage A of the SCIPIO trial, patients with post-infarction LV dysfunction (ejection fraction [EF] ≤40%) before coronary artery bypass grafting were consecutively enrolled in the treatment and control groups. In stage B, patients were randomly assigned to the treatment or control group in a 2:3 ratio by use of a computer-generated block randomisation scheme. 1 million autologous CSCs were administered by intracoronary infusion at a mean of 113 days (SE 4) after surgery; controls were not given any treatment. Although the study was open label, the echocardiographic analyses were masked to group assignment. The primary endpoint was short-term safety of CSCs and the secondary endpoint was efficacy. A per-protocol analysis was used. This study is registered with ClinicalTrials.gov , number NCT00474461. Findings This study is still in progress. 16 patients were assigned to the treatment group and seven to the control group; no CSC-related adverse effects were reported. In 14 CSC-treated patients who were analysed, LVEF increased from 30·3% (SE 1·9) before CSC infusion to 38·5% (2·8) at 4 months after infusion (p=0·001). By contrast, in seven control patients, during the corresponding time interval, LVEF did not change (30·1% [2·4] at 4 months after CABG vs 30·2% [2·5] at 8 months after CABG). Importantly, the salubrious effects of CSCs were even more pronounced at 1 year in eight patients (eg, LVEF increased by 12·3 ejection fraction units [2·1] vs baseline, p=0·0007). In the seven treated patients in whom cardiac MRI could be done, infarct size decreased from 32·6 g (6·3) by 7·8 g (1·7; 24%) at 4 months (p=0·004) and 9·8 g (3·5; 30%) at 1 year (p=0·04). Interpretation These initial results in patients are very encouraging. They suggest that intracoronary infusion of autologous CSCs is effective in improving LV systolic function and reducing infarct size in patients with heart failure after myocardial infarction, and warrant further, larger, phase 2 studies. Funding University of Louisville Research Foundation and National Institutes of Health.
subject
0Abridged Index Medicus
1Autografts
2Biological and medical sciences
3c-Kit protein
4Cardiology
5Cardiology. Vascular system
6Cardiomyopathy
7Cardiovascular disease
8Care and treatment
9Combined Modality Therapy
10Coronary artery
11Coronary Artery Bypass - methods
12Coronary artery disease
13Coronary Vessels
14Design
15Diagnosis
16Echocardiography, Doppler - methods
17Evidence-based medicine
18FDA approval
19Female
20Follow-Up Studies
21General aspects
22Heart
23Heart attacks
24Heart cells
25Heart diseases
26Heart failure
27Heart Failure - prevention & control
28Heart Failure - therapy
29Heart surgery
30Humans
31Injections, Intra-Arterial
32Internal Medicine
33Ischemia
34Laboratories
35Magnetic resonance imaging
36Magnetic Resonance Imaging - methods
37Male
38Medical sciences
39Methods
40Middle Aged
41Mortality
42Myocardial infarction
43Myocardial Infarction - diagnosis
44Myocardial Infarction - mortality
45Myocardial Infarction - therapy
46Myocardial ischemia
47Myocardial Ischemia - diagnosis
48Myocardial Ischemia - mortality
49Myocardial Ischemia - therapy
50Myocarditis. Cardiomyopathies
51Myocytes, Cardiac - transplantation
52Patients
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54Postoperative Care - methods
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57Reference Values
58Review boards
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61Stem Cell Transplantation - methods
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65Survival Analysis
66Time Factors
67Tissue and Organ Harvesting
68Transplantation
69Transplantation, Autologous - methods
70Treatment Outcome
71Veins & arteries
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73Ventricular Remodeling - physiology
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titleCardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial
authorBolli, Roberto, Prof ; Chugh, Atul R, MD ; D'Amario, Domenico, MD ; Loughran, John H, MD ; Stoddard, Marcus F, Prof ; Ikram, Sohail, Prof ; Beache, Garth M, MD ; Wagner, Stephen G, MD ; Leri, Annarosa, MD ; Hosoda, Toru, MD ; Sanada, Fumihiro, MD ; Elmore, Julius B, MD ; Goichberg, Polina, PhD ; Cappetta, Donato, PhD ; Solankhi, Naresh K, MD ; Fahsah, Ibrahim, MD ; Rokosh, D Gregg, PhD ; Slaughter, Mark S, Prof ; Kajstura, Jan, PhD ; Anversa, Piero, Prof
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1Autografts
2Biological and medical sciences
3c-Kit protein
4Cardiology
5Cardiology. Vascular system
6Cardiomyopathy
7Cardiovascular disease
8Care and treatment
9Combined Modality Therapy
10Coronary artery
11Coronary Artery Bypass - methods
12Coronary artery disease
13Coronary Vessels
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42Myocardial infarction
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44Myocardial Infarction - mortality
45Myocardial Infarction - therapy
46Myocardial ischemia
47Myocardial Ischemia - diagnosis
48Myocardial Ischemia - mortality
49Myocardial Ischemia - therapy
50Myocarditis. Cardiomyopathies
51Myocytes, Cardiac - transplantation
52Patients
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54Postoperative Care - methods
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56Randomization
57Reference Values
58Review boards
59Risk Assessment
60Stem cell transplantation
61Stem Cell Transplantation - methods
62Stem cells
63Studies
64Surgery
65Survival Analysis
66Time Factors
67Tissue and Organ Harvesting
68Transplantation
69Transplantation, Autologous - methods
70Treatment Outcome
71Veins & arteries
72Ventricle
73Ventricular Remodeling - physiology
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6Beache, Garth M, MD
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8Leri, Annarosa, MD
9Hosoda, Toru, MD
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12Goichberg, Polina, PhD
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14Solankhi, Naresh K, MD
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jtitleThe Lancet (British edition)
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
au
0Bolli, Roberto, Prof
1Chugh, Atul R, MD
2D'Amario, Domenico, MD
3Loughran, John H, MD
4Stoddard, Marcus F, Prof
5Ikram, Sohail, Prof
6Beache, Garth M, MD
7Wagner, Stephen G, MD
8Leri, Annarosa, MD
9Hosoda, Toru, MD
10Sanada, Fumihiro, MD
11Elmore, Julius B, MD
12Goichberg, Polina, PhD
13Cappetta, Donato, PhD
14Solankhi, Naresh K, MD
15Fahsah, Ibrahim, MD
16Rokosh, D Gregg, PhD
17Slaughter, Mark S, Prof
18Kajstura, Jan, PhD
19Anversa, Piero, Prof
formatjournal
genrearticle
ristypeJOUR
atitleCardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial
jtitleThe Lancet (British edition)
addtitleLancet
date2011
risdate2011
volume378
issue9806
spage1847
epage1857
pages1847-1857
issn0140-6736
eissn1474-547X
codenLANCAO
abstractSummary Background c-kit-positive, lineage-negative cardiac stem cells (CSCs) improve post-infarction left ventricular (LV) dysfunction when administered to animals. We undertook a phase 1 trial (Stem Cell Infusion in Patients with Ischemic cardiOmyopathy [SCIPIO]) of autologous CSCs for the treatment of heart failure resulting from ischaemic heart disease. Methods In stage A of the SCIPIO trial, patients with post-infarction LV dysfunction (ejection fraction [EF] ≤40%) before coronary artery bypass grafting were consecutively enrolled in the treatment and control groups. In stage B, patients were randomly assigned to the treatment or control group in a 2:3 ratio by use of a computer-generated block randomisation scheme. 1 million autologous CSCs were administered by intracoronary infusion at a mean of 113 days (SE 4) after surgery; controls were not given any treatment. Although the study was open label, the echocardiographic analyses were masked to group assignment. The primary endpoint was short-term safety of CSCs and the secondary endpoint was efficacy. A per-protocol analysis was used. This study is registered with ClinicalTrials.gov , number NCT00474461. Findings This study is still in progress. 16 patients were assigned to the treatment group and seven to the control group; no CSC-related adverse effects were reported. In 14 CSC-treated patients who were analysed, LVEF increased from 30·3% (SE 1·9) before CSC infusion to 38·5% (2·8) at 4 months after infusion (p=0·001). By contrast, in seven control patients, during the corresponding time interval, LVEF did not change (30·1% [2·4] at 4 months after CABG vs 30·2% [2·5] at 8 months after CABG). Importantly, the salubrious effects of CSCs were even more pronounced at 1 year in eight patients (eg, LVEF increased by 12·3 ejection fraction units [2·1] vs baseline, p=0·0007). In the seven treated patients in whom cardiac MRI could be done, infarct size decreased from 32·6 g (6·3) by 7·8 g (1·7; 24%) at 4 months (p=0·004) and 9·8 g (3·5; 30%) at 1 year (p=0·04). Interpretation These initial results in patients are very encouraging. They suggest that intracoronary infusion of autologous CSCs is effective in improving LV systolic function and reducing infarct size in patients with heart failure after myocardial infarction, and warrant further, larger, phase 2 studies. Funding University of Louisville Research Foundation and National Institutes of Health.
copKidlington
pubElsevier Ltd
pmid22088800
doi10.1016/S0140-6736(11)61590-0
oafree_for_read