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Article: Prospective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT-CAD trial)
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TitleProspective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT-CAD trial)
 
AuthorsTse, HF1
Thambar, S3
Kwong, YL1
Rowlings, P5
Bellamy, G3
McCrohon, J5
Thomas, P6
Bastian, B3
Chan, JKF7
Lo, G7
Ho, CL7
Chan, WS1
Kwong, RY4
Parker, A2
Hauser, TH2
Chan, J1
Fong, DYT1
Lau, CP1
 
KeywordsAngiogenesis
Bone marrow
Coronary artery disease
 
Issue Date2007
 
PublisherOxford University Press. The Journal's web site is located at http://eurheartj.oxfordjournals.org/
 
CitationEuropean Heart Journal, 2007, v. 28 n. 24, p. 2998-3005 [How to Cite?]
DOI: http://dx.doi.org/10.1093/eurheartj/ehm485
 
AbstractAims: Experimental studies have demonstrated that bone marrow (BM) cells can induce angiogenesis in ischaemic myocardium. Recently, several non-randomized pilot studies have also suggested that direct BM cells implantation appears to be feasible and safe in patients with severe coronary artery diseases (CAD). Methods and results: We performed a randomized, blinded, and placebo-controlled trial in 28 CAD patients. After BM harvesting, we assigned patients to receive low dose (1 × 106 cells/0.1 mL, n = 9), high dose (2 × 106 cells/0.1 mL, n = 10) autologous BM cells or control (0.1 mL autologous plasma/injection, n = 9) catheter-based direct endomyocardial injection as guided by electromechanical mapping. Our primary endpoint was the increase in exercise treadmill time and our secondary endpoints were changes in Canadian Cardiovascular Society (CCS) and New York Heart Association (NYHA) class, and myocardial perfusion and left ventricular ejection fraction (LVEF) assessed by single-photon emission computed tomography and magnetic resonance imaging, respectively. A total 422 injections (mean 14.6 ± 0.7 per patient) were successfully performed at 41 targeted ischaemic regions without any acute complication. Baseline exercise treadmill time was 439 ± 182 s in controls and 393 ± 136 s in BM-treated patients, and changed after 6 months to 383 ± 223s and 464 ± 196 s [BM treatment effect +0.43 log seconds (+53%), 95% CI 0.11-0.74, P = 0.014]. Compared with placebo injection, BM implantation was associated with a significant increase in LVEF (BM treatment effect +5.4%, 95% CI 0.4-10.3, P = 0.044) and a lower NYHA class (odds ratio for treatment effect 0.12, 95% CI 0.02-0.73, P = 0.021) after 6 months, but CCS reduced similarly in both groups. We observed no acute or long-term complications, including ventricular arrhythmia, myocardial damage, or development of intramyocardial tumour or calcification associated with BM implantation. Conclusion: Direct endomyocardial implantation of autologous BM cells significantly improved exercise time, LVEF, and NYHA functional class in patients with severe CAD who failed conventional therapy. © The Author 2007.
 
ISSN0195-668X
2012 Impact Factor: 14.097
2012 SCImago Journal Rankings: 4.823
 
DOIhttp://dx.doi.org/10.1093/eurheartj/ehm485
 
ISI Accession Number IDWOS:000251680600012
 
ReferencesReferences in Scopus
 
DC FieldValue
dc.contributor.authorTse, HF
 
dc.contributor.authorThambar, S
 
dc.contributor.authorKwong, YL
 
dc.contributor.authorRowlings, P
 
dc.contributor.authorBellamy, G
 
dc.contributor.authorMcCrohon, J
 
dc.contributor.authorThomas, P
 
dc.contributor.authorBastian, B
 
dc.contributor.authorChan, JKF
 
dc.contributor.authorLo, G
 
dc.contributor.authorHo, CL
 
dc.contributor.authorChan, WS
 
dc.contributor.authorKwong, RY
 
dc.contributor.authorParker, A
 
dc.contributor.authorHauser, TH
 
dc.contributor.authorChan, J
 
dc.contributor.authorFong, DYT
 
dc.contributor.authorLau, CP
 
dc.date.accessioned2010-10-31T12:30:57Z
 
dc.date.available2010-10-31T12:30:57Z
 
dc.date.issued2007
 
dc.description.abstractAims: Experimental studies have demonstrated that bone marrow (BM) cells can induce angiogenesis in ischaemic myocardium. Recently, several non-randomized pilot studies have also suggested that direct BM cells implantation appears to be feasible and safe in patients with severe coronary artery diseases (CAD). Methods and results: We performed a randomized, blinded, and placebo-controlled trial in 28 CAD patients. After BM harvesting, we assigned patients to receive low dose (1 × 106 cells/0.1 mL, n = 9), high dose (2 × 106 cells/0.1 mL, n = 10) autologous BM cells or control (0.1 mL autologous plasma/injection, n = 9) catheter-based direct endomyocardial injection as guided by electromechanical mapping. Our primary endpoint was the increase in exercise treadmill time and our secondary endpoints were changes in Canadian Cardiovascular Society (CCS) and New York Heart Association (NYHA) class, and myocardial perfusion and left ventricular ejection fraction (LVEF) assessed by single-photon emission computed tomography and magnetic resonance imaging, respectively. A total 422 injections (mean 14.6 ± 0.7 per patient) were successfully performed at 41 targeted ischaemic regions without any acute complication. Baseline exercise treadmill time was 439 ± 182 s in controls and 393 ± 136 s in BM-treated patients, and changed after 6 months to 383 ± 223s and 464 ± 196 s [BM treatment effect +0.43 log seconds (+53%), 95% CI 0.11-0.74, P = 0.014]. Compared with placebo injection, BM implantation was associated with a significant increase in LVEF (BM treatment effect +5.4%, 95% CI 0.4-10.3, P = 0.044) and a lower NYHA class (odds ratio for treatment effect 0.12, 95% CI 0.02-0.73, P = 0.021) after 6 months, but CCS reduced similarly in both groups. We observed no acute or long-term complications, including ventricular arrhythmia, myocardial damage, or development of intramyocardial tumour or calcification associated with BM implantation. Conclusion: Direct endomyocardial implantation of autologous BM cells significantly improved exercise time, LVEF, and NYHA functional class in patients with severe CAD who failed conventional therapy. © The Author 2007.
 
dc.description.naturelink_to_subscribed_fulltext
 
dc.identifier.citationEuropean Heart Journal, 2007, v. 28 n. 24, p. 2998-3005 [How to Cite?]
DOI: http://dx.doi.org/10.1093/eurheartj/ehm485
 
dc.identifier.doihttp://dx.doi.org/10.1093/eurheartj/ehm485
 
dc.identifier.eissn1522-9645
 
dc.identifier.epage3005
 
dc.identifier.hkuros174709
 
dc.identifier.hkuros140838
 
dc.identifier.isiWOS:000251680600012
 
dc.identifier.issn0195-668X
2012 Impact Factor: 14.097
2012 SCImago Journal Rankings: 4.823
 
dc.identifier.issue24
 
dc.identifier.openurl
 
dc.identifier.pmid17984132
 
dc.identifier.scopuseid_2-s2.0-37249084757
 
dc.identifier.spage2998
 
dc.identifier.urihttp://hdl.handle.net/10722/126477
 
dc.identifier.volume28
 
dc.languageeng
 
dc.publisherOxford University Press. The Journal's web site is located at http://eurheartj.oxfordjournals.org/
 
dc.publisher.placeUnited Kingdom
 
dc.relation.ispartofEuropean Heart Journal
 
dc.relation.referencesReferences in Scopus
 
dc.rightsEuropean Heart Journal. Copyright © Oxford University Press.
 
dc.subject.meshAcute Disease
 
dc.subject.meshAged
 
dc.subject.meshBone Marrow Transplantation - methods
 
dc.subject.meshCoronary Artery Disease - diagnosis - surgery
 
dc.subject.meshExercise Test - methods
 
dc.subject.meshFemale
 
dc.subject.meshFollow-Up Studies
 
dc.subject.meshHumans
 
dc.subject.meshMagnetic Resonance Angiography - methods
 
dc.subject.meshMale
 
dc.subject.meshProspective Studies
 
dc.subject.meshTomography, Emission-Computed, Single-Photon - methods
 
dc.subjectAngiogenesis
 
dc.subjectBone marrow
 
dc.subjectCoronary artery disease
 
dc.titleProspective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT-CAD trial)
 
dc.typeArticle
 
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<contributor.author>Bellamy, G</contributor.author>
<contributor.author>McCrohon, J</contributor.author>
<contributor.author>Thomas, P</contributor.author>
<contributor.author>Bastian, B</contributor.author>
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<description.abstract>Aims: Experimental studies have demonstrated that bone marrow (BM) cells can induce angiogenesis in ischaemic myocardium. Recently, several non-randomized pilot studies have also suggested that direct BM cells implantation appears to be feasible and safe in patients with severe coronary artery diseases (CAD). Methods and results: We performed a randomized, blinded, and placebo-controlled trial in 28 CAD patients. After BM harvesting, we assigned patients to receive low dose (1 &#215; 106 cells/0.1 mL, n = 9), high dose (2 &#215; 106 cells/0.1 mL, n = 10) autologous BM cells or control (0.1 mL autologous plasma/injection, n = 9) catheter-based direct endomyocardial injection as guided by electromechanical mapping. Our primary endpoint was the increase in exercise treadmill time and our secondary endpoints were changes in Canadian Cardiovascular Society (CCS) and New York Heart Association (NYHA) class, and myocardial perfusion and left ventricular ejection fraction (LVEF) assessed by single-photon emission computed tomography and magnetic resonance imaging, respectively. A total 422 injections (mean 14.6 &#177; 0.7 per patient) were successfully performed at 41 targeted ischaemic regions without any acute complication. Baseline exercise treadmill time was 439 &#177; 182 s in controls and 393 &#177; 136 s in BM-treated patients, and changed after 6 months to 383 &#177; 223s and 464 &#177; 196 s [BM treatment effect +0.43 log seconds (+53%), 95% CI 0.11-0.74, P = 0.014]. Compared with placebo injection, BM implantation was associated with a significant increase in LVEF (BM treatment effect +5.4%, 95% CI 0.4-10.3, P = 0.044) and a lower NYHA class (odds ratio for treatment effect 0.12, 95% CI 0.02-0.73, P = 0.021) after 6 months, but CCS reduced similarly in both groups. We observed no acute or long-term complications, including ventricular arrhythmia, myocardial damage, or development of intramyocardial tumour or calcification associated with BM implantation. Conclusion: Direct endomyocardial implantation of autologous BM cells significantly improved exercise time, LVEF, and NYHA functional class in patients with severe CAD who failed conventional therapy. &#169; The Author 2007.</description.abstract>
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Author Affiliations
  1. The University of Hong Kong
  2. Harvard Medical School
  3. John Hunter Hospital
  4. Brigham and Women's Hospital
  5. Newcastle Mater Misericordiae Hospital
  6. St George Hospital
  7. Hong Kong Sanatorium and Hospital