Article: Prospective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT-CAD trial)

File Download Links for fulltext
(May Require Subscription)
Supplementary
  • Basic View
  • Metadata View
  • XML View
TitleProspective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT-CAD trial)
AuthorsTse, HF2
Thambar, S3
Kwong, YL2
Rowlings, P6
Bellamy, G3
McCrohon, J6
Thomas, P5
Bastian, B3
Chan, JKF7
Lo, G7
Ho, CL7
Chan, WS2
Kwong, RY4
Parker, A1
Hauser, TH1
Chan, J2
Fong, DYT2
Lau, CP2
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
2011 Impact Factor: 10.478
2011 SCImago Journal Rankings: 0.801
DOIhttp://dx.doi.org/10.1093/eurheartj/ehm485
ISI Accession Number IDWOS:000251680600012
ReferencesReferences in Scopus
DC Field
Value
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.epage3005
dc.identifier.hkuros174709
dc.identifier.hkuros140838
dc.identifier.isiWOS:000251680600012
dc.identifier.issn0195-668X
2011 Impact Factor: 10.478
2011 SCImago Journal Rankings: 0.801
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
Author Affiliations
  1. Harvard Medical School
  2. The University of Hong Kong
  3. John Hunter Hospital
  4. Brigham and Women's Hospital
  5. St George Hospital
  6. Newcastle Mater Misericordiae Hospital
  7. Hong Kong Sanatorium and Hospital