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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
Subjects:
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
  • Analysis
  • Autografts
  • Biological and medical sciences
  • c-Kit protein
  • Cardiac patients
  • Cardiology
  • Cardiology. Vascular system
  • Cardiomyopathy
  • Cardiovascular disease
  • Care and treatment
  • Clinical trials
  • Combined Modality Therapy
  • Coronary artery
  • Coronary artery bypass
  • 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
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3PMID: 22088800
4CODEN: LANCAO
languageeng
publisherKidlington: Elsevier Ltd
subjectAbridged Index Medicus ; Analysis ; Autografts ; Biological and medical sciences ; c-Kit protein ; Cardiac patients ; Cardiology ; Cardiology. Vascular system ; Cardiomyopathy ; Cardiovascular disease ; Care and treatment ; Clinical trials ; Combined Modality Therapy ; Coronary artery ; Coronary artery bypass ; 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
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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)
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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
1Analysis
2Autografts
3Biological and medical sciences
4c-Kit protein
5Cardiac patients
6Cardiology
7Cardiology. Vascular system
8Cardiomyopathy
9Cardiovascular disease
10Care and treatment
11Clinical trials
12Combined Modality Therapy
13Coronary artery
14Coronary artery bypass
15Coronary Artery Bypass - methods
16Coronary artery disease
17Coronary Vessels
18Design
19Diagnosis
20Echocardiography, Doppler - methods
21Evidence-based medicine
22FDA approval
23Female
24Follow-Up Studies
25General aspects
26Heart
27Heart attacks
28Heart cells
29Heart diseases
30Heart failure
31Heart Failure - prevention & control
32Heart Failure - therapy
33Heart surgery
34Humans
35Injections, Intra-Arterial
36Internal Medicine
37Ischemia
38Laboratories
39Magnetic resonance imaging
40Magnetic Resonance Imaging - methods
41Male
42Medical sciences
43Methods
44Middle Aged
45Mortality
46Myocardial infarction
47Myocardial Infarction - diagnosis
48Myocardial Infarction - mortality
49Myocardial Infarction - therapy
50Myocardial ischemia
51Myocardial Ischemia - diagnosis
52Myocardial Ischemia - mortality
53Myocardial Ischemia - therapy
54Myocarditis. Cardiomyopathies
55Myocytes, Cardiac - transplantation
56Patients
57Physiological aspects
58Postoperative Care - methods
59Prospective Studies
60Randomization
61Reference Values
62Review boards
63Risk Assessment
64Stem cell transplantation
65Stem Cell Transplantation - methods
66Stem cells
67Studies
68Surgery
69Survival Analysis
70Time Factors
71Tissue and Organ Harvesting
72Transplantation
73Transplantation, Autologous - methods
74Treatment Outcome
75Veins & arteries
76Ventricle
77Ventricular 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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0Abridged Index Medicus
1Analysis
2Autografts
3Biological and medical sciences
4c-Kit protein
5Cardiac patients
6Cardiology
7Cardiology. Vascular system
8Cardiomyopathy
9Cardiovascular disease
10Care and treatment
11Clinical trials
12Combined Modality Therapy
13Coronary artery
14Coronary artery bypass
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16Coronary artery disease
17Coronary Vessels
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19Diagnosis
20Echocardiography, Doppler - methods
21Evidence-based medicine
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24Follow-Up Studies
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26Heart
27Heart attacks
28Heart cells
29Heart diseases
30Heart failure
31Heart Failure - prevention & control
32Heart Failure - therapy
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36Internal Medicine
37Ischemia
38Laboratories
39Magnetic resonance imaging
40Magnetic Resonance Imaging - methods
41Male
42Medical sciences
43Methods
44Middle Aged
45Mortality
46Myocardial infarction
47Myocardial Infarction - diagnosis
48Myocardial Infarction - mortality
49Myocardial Infarction - therapy
50Myocardial ischemia
51Myocardial Ischemia - diagnosis
52Myocardial Ischemia - mortality
53Myocardial Ischemia - therapy
54Myocarditis. Cardiomyopathies
55Myocytes, Cardiac - transplantation
56Patients
57Physiological aspects
58Postoperative Care - methods
59Prospective Studies
60Randomization
61Reference Values
62Review boards
63Risk Assessment
64Stem cell transplantation
65Stem Cell Transplantation - methods
66Stem cells
67Studies
68Surgery
69Survival Analysis
70Time Factors
71Tissue and Organ Harvesting
72Transplantation
73Transplantation, Autologous - methods
74Treatment Outcome
75Veins & arteries
76Ventricle
77Ventricular Remodeling - physiology
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1Chugh, Atul R, MD
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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
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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