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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)

TitleProspective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT-CAD trial)
Authors
KeywordsAngiogenesis
Bone marrow
Coronary artery disease
Issue Date2007
PublisherOxford University Press. The Journal's web site is located at http://eurheartj.oxfordjournals.org/
Citation
European Heart Journal, 2007, v. 28 n. 24, p. 2998-3005 How to Cite?
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 × 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.
Persistent Identifierhttp://hdl.handle.net/10722/126477
ISSN
2013 Impact Factor: 14.723
ISI Accession Number ID
References

 

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
DC FieldValueLanguage
dc.contributor.authorTse, HFen_HK
dc.contributor.authorThambar, Sen_HK
dc.contributor.authorKwong, YLen_HK
dc.contributor.authorRowlings, Pen_HK
dc.contributor.authorBellamy, Gen_HK
dc.contributor.authorMcCrohon, Jen_HK
dc.contributor.authorThomas, Pen_HK
dc.contributor.authorBastian, Ben_HK
dc.contributor.authorChan, JKFen_HK
dc.contributor.authorLo, Gen_HK
dc.contributor.authorHo, CLen_HK
dc.contributor.authorChan, WSen_HK
dc.contributor.authorKwong, RYen_HK
dc.contributor.authorParker, Aen_HK
dc.contributor.authorHauser, THen_HK
dc.contributor.authorChan, Jen_HK
dc.contributor.authorFong, DYTen_HK
dc.contributor.authorLau, CPen_HK
dc.date.accessioned2010-10-31T12:30:57Z-
dc.date.available2010-10-31T12:30:57Z-
dc.date.issued2007en_HK
dc.identifier.citationEuropean Heart Journal, 2007, v. 28 n. 24, p. 2998-3005en_HK
dc.identifier.issn0195-668Xen_HK
dc.identifier.urihttp://hdl.handle.net/10722/126477-
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.en_HK
dc.languageengen_HK
dc.publisherOxford University Press. The Journal's web site is located at http://eurheartj.oxfordjournals.org/en_HK
dc.relation.ispartofEuropean Heart Journalen_HK
dc.rightsEuropean Heart Journal. Copyright © Oxford University Press.-
dc.subjectAngiogenesis-
dc.subjectBone marrow-
dc.subjectCoronary artery disease-
dc.subject.meshAcute Diseaseen_HK
dc.subject.meshAgeden_HK
dc.subject.meshBone Marrow Transplantation - methodsen_HK
dc.subject.meshCoronary Artery Disease - diagnosis - surgeryen_HK
dc.subject.meshExercise Test - methodsen_HK
dc.subject.meshFemaleen_HK
dc.subject.meshFollow-Up Studiesen_HK
dc.subject.meshHumansen_HK
dc.subject.meshMagnetic Resonance Angiography - methodsen_HK
dc.subject.meshMaleen_HK
dc.subject.meshProspective Studiesen_HK
dc.subject.meshTomography, Emission-Computed, Single-Photon - methodsen_HK
dc.titleProspective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT-CAD trial)en_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0195-668X&volume=28&spage=&epage=&date=2007&atitle=Prospective+randomized+trial+of+direct+endomyocardial+implantation+of+bone+marrow+cells+for+treatment+of+severe+coronary+artery+diseases+(PROTECT-CAD+trial)en_HK
dc.identifier.emailTse, HF:hftse@hkucc.hku.hken_HK
dc.identifier.emailKwong, YL:ylkwong@hku.hken_HK
dc.identifier.authorityTse, HF=rp00428en_HK
dc.identifier.authorityKwong, YL=rp00358en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1093/eurheartj/ehm485en_HK
dc.identifier.pmid17984132en_HK
dc.identifier.scopuseid_2-s2.0-37249084757en_HK
dc.identifier.hkuros174709en_HK
dc.identifier.hkuros140838-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-37249084757&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume28en_HK
dc.identifier.issue24en_HK
dc.identifier.spage2998en_HK
dc.identifier.epage3005en_HK
dc.identifier.eissn1522-9645-
dc.identifier.isiWOS:000251680600012-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridTse, HF=7006070805en_HK
dc.identifier.scopusauthoridThambar, S=6508108817en_HK
dc.identifier.scopusauthoridKwong, YL=7102818954en_HK
dc.identifier.scopusauthoridRowlings, P=7003519846en_HK
dc.identifier.scopusauthoridBellamy, G=7006844978en_HK
dc.identifier.scopusauthoridMcCrohon, J=6602810028en_HK
dc.identifier.scopusauthoridThomas, P=7404889769en_HK
dc.identifier.scopusauthoridBastian, B=7005685003en_HK
dc.identifier.scopusauthoridChan, JKF=7403287057en_HK
dc.identifier.scopusauthoridLo, G=7101880732en_HK
dc.identifier.scopusauthoridHo, CL=7404653628en_HK
dc.identifier.scopusauthoridChan, WS=13104241000en_HK
dc.identifier.scopusauthoridKwong, RY=7005246098en_HK
dc.identifier.scopusauthoridParker, A=7403267925en_HK
dc.identifier.scopusauthoridHauser, TH=7006380610en_HK
dc.identifier.scopusauthoridChan, J=23090202000en_HK
dc.identifier.scopusauthoridFong, DYT=35261710300en_HK
dc.identifier.scopusauthoridLau, CP=7401968501en_HK

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