PMID- 17984132
OWN - NLM
STAT- MEDLINE
DCOM- 20080410
LR  - 20231024
IS  - 0195-668X (Print)
IS  - 0195-668X (Linking)
VI  - 28
IP  - 24
DP  - 2007 Dec
TI  - Prospective randomized trial of direct endomyocardial implantation of bone marrow 
      cells for treatment of severe coronary artery diseases (PROTECT-CAD trial).
PG  - 2998-3005
AB  - 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 
      x 10(6) cells/0.1 mL, n = 9), high dose (2 x 10(6) 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.
FAU - Tse, Hung-Fat
AU  - Tse HF
AD  - Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong. 
      hftse@hkucc.hku.hk
FAU - Thambar, Sukumaran
AU  - Thambar S
FAU - Kwong, Yok-Lam
AU  - Kwong YL
FAU - Rowlings, Philip
AU  - Rowlings P
FAU - Bellamy, Greg
AU  - Bellamy G
FAU - McCrohon, Jane
AU  - McCrohon J
FAU - Thomas, Paul
AU  - Thomas P
FAU - Bastian, Bruce
AU  - Bastian B
FAU - Chan, John K F
AU  - Chan JK
FAU - Lo, Gladys
AU  - Lo G
FAU - Ho, Chi-Lai
AU  - Ho CL
FAU - Chan, Wing-Sze
AU  - Chan WS
FAU - Kwong, Raymond Y
AU  - Kwong RY
FAU - Parker, Anthony
AU  - Parker A
FAU - Hauser, Thomas H
AU  - Hauser TH
FAU - Chan, Jenny
AU  - Chan J
FAU - Fong, Daniel Y T
AU  - Fong DY
FAU - Lau, Chu-Pak
AU  - Lau CP
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20071105
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
SB  - IM
CIN - Nat Clin Pract Cardiovasc Med. 2008 Jul;5(7):362-3. PMID: 18490941
MH  - Acute Disease
MH  - Aged
MH  - Bone Marrow Transplantation/*methods
MH  - Coronary Artery Disease/diagnosis/*surgery
MH  - Exercise Test/methods
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Magnetic Resonance Angiography/methods
MH  - Male
MH  - Prospective Studies
MH  - Tomography, Emission-Computed, Single-Photon/methods
EDAT- 2007/11/07 09:00
MHDA- 2008/04/11 09:00
CRDT- 2007/11/07 09:00
PHST- 2007/11/07 09:00 [pubmed]
PHST- 2008/04/11 09:00 [medline]
PHST- 2007/11/07 09:00 [entrez]
AID - ehm485 [pii]
AID - 10.1093/eurheartj/ehm485 [doi]
PST - ppublish
SO  - Eur Heart J. 2007 Dec;28(24):2998-3005. doi: 10.1093/eurheartj/ehm485. Epub 2007 
      Nov 5.