PMID- 27322478
OWN - NLM
STAT- MEDLINE
DCOM- 20170306
LR  - 20220317
IS  - 2352-3964 (Electronic)
IS  - 2352-3964 (Linking)
VI  - 7
DP  - 2016 May
TI  - First-in-man Safety and Efficacy of the Adipose Graft Transposition Procedure 
      (AGTP) in Patients With a Myocardial Scar.
PG  - 248-54
LID - S2352-3964(16)30113-X [pii]
LID - 10.1016/j.ebiom.2016.03.027 [doi]
AB  - BACKGROUND: The present study evaluates the safety and efficacy of the Adipose 
      Graft Transposition Procedure (AGTP) as a biological regenerative innovation for 
      patients with a chronic myocardial scar. METHODS: This prospective, randomized 
      single-center controlled study included 10 patients with established chronic 
      transmural myocardial scars. Candidates for myocardial revascularization were 
      randomly allocated into two treatment groups. In the control arm (n=5), the 
      revascularizable area was treated with CABG and the non-revascularizable area was 
      left untouched. Patients in the AGTP-treated arm (n=5) were treated with CABG and 
      the non-revascularizable area was covered by a biological adipose graft. The 
      primary endpoint was the appearance of adverse effects derived from the procedure 
      including hospital admissions and death, and 24-hour Holter monitoring 
      arrhythmias at baseline, 1week, and 3 and 12months. Secondary endpoints of 
      efficacy were assessed by cardiac MRI. FINDINGS: No differences in safety were 
      observed between groups in terms of clinical or arrhythmic events. On follow-up 
      MRI testing, participants in the AGTP-treated arm showed a borderline smaller 
      left ventricular end systolic volume (LVESV; p=0.09) and necrosis ratio (p=0.06) 
      at 3months but not at 12months. The AGTP-treated patient with the largest 
      necrotic area and most dilated chambers experienced a noted improvement in 
      necrotic mass size (-10.8%), and ventricular volumes (LVEDV: -55.2mL and LVESV: 
      -37.8mL at one year follow-up) after inferior AGTP. INTERPRETATION: Our results 
      indicate that AGTP is safe and may be efficacious in selected patients. Further 
      studies are needed to assess its clinical value. (ClinicalTrials.org NCT01473433, 
      AdiFlap Trial).
CI  - Copyright (c) 2016 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Bayes-Genis, Antoni
AU  - Bayes-Genis A
AD  - Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain; 
      Department of Medicine, Universitat Autonoma de Barcelona, Barcelona, Spain; 
      ICREC Research Program, Health Science Research Institute Germans Trias i Pujol, 
      Badalona, Spain. Electronic address: abayes.germanstrias@gencat.cat.
FAU - Gastelurrutia, Paloma
AU  - Gastelurrutia P
AD  - ICREC Research Program, Health Science Research Institute Germans Trias i Pujol, 
      Badalona, Spain.
FAU - Camara, Maria-Luisa
AU  - Camara ML
AD  - Cardiac Surgery Service, Germans Trias i Pujol University Hospital, Badalona, 
      Spain.
FAU - Teis, Albert
AU  - Teis A
AD  - Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain; 
      Clinica Creu Blanca, Barcelona, Spain.
FAU - Lupon, Josep
AU  - Lupon J
AD  - Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain; 
      Department of Medicine, Universitat Autonoma de Barcelona, Barcelona, Spain.
FAU - Llibre, Cinta
AU  - Llibre C
AD  - Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain.
FAU - Zamora, Elisabet
AU  - Zamora E
AD  - Cardiology Service, Germans Trias i Pujol University Hospital, Badalona, Spain.
FAU - Alomar, Xavier
AU  - Alomar X
AD  - Clinica Creu Blanca, Barcelona, Spain.
FAU - Ruyra, Xavier
AU  - Ruyra X
AD  - Cardiac Surgery Service, Germans Trias i Pujol University Hospital, Badalona, 
      Spain.
FAU - Roura, Santiago
AU  - Roura S
AD  - ICREC Research Program, Health Science Research Institute Germans Trias i Pujol, 
      Badalona, Spain; Center of Regenerative Medicine in Barcelona, Barcelona, Spain.
FAU - Revilla, Ana
AU  - Revilla A
AD  - ICICORELAB, Clinic University Hospital, Valladolid, Spain.
FAU - San Roman, Jose Alberto
AU  - San Roman JA
AD  - ICICORELAB, Clinic University Hospital, Valladolid, Spain.
FAU - Galvez-Monton, Carolina
AU  - Galvez-Monton C
AD  - ICREC Research Program, Health Science Research Institute Germans Trias i Pujol, 
      Badalona, Spain.
LA  - eng
SI  - ClinicalTrials.gov/NCT01473433
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160410
PL  - Netherlands
TA  - EBioMedicine
JT  - EBioMedicine
JID - 101647039
SB  - IM
CIN - EBioMedicine. 2016 May;7:25-6. PMID: 27322455
MH  - Adipose Tissue/*transplantation
MH  - Aged
MH  - Cardiac Volume
MH  - Cicatrix/*therapy
MH  - Coronary Artery Bypass/*methods
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myocardial Infarction/*surgery
MH  - Prospective Studies
MH  - Regeneration
MH  - Transplantation, Autologous
MH  - Treatment Outcome
PMC - PMC4909363
OTO - NOTNLM
OT  - Adipose tissue
OT  - Cardiac surgery
OT  - Cardiac tissue engineering
OT  - Myocardial infarction
OT  - Regenerative medicine
OT  - Stem cell therapy
EDAT- 2016/06/21 06:00
MHDA- 2017/03/07 06:00
PMCR- 2016/04/10
CRDT- 2016/06/21 06:00
PHST- 2016/02/05 00:00 [received]
PHST- 2016/03/16 00:00 [revised]
PHST- 2016/03/17 00:00 [accepted]
PHST- 2016/06/21 06:00 [entrez]
PHST- 2016/06/21 06:00 [pubmed]
PHST- 2017/03/07 06:00 [medline]
PHST- 2016/04/10 00:00 [pmc-release]
AID - S2352-3964(16)30113-X [pii]
AID - 10.1016/j.ebiom.2016.03.027 [doi]
PST - ppublish
SO  - EBioMedicine. 2016 May;7:248-54. doi: 10.1016/j.ebiom.2016.03.027. Epub 2016 Apr 
      10.