PMID- 24130088
OWN - NLM
STAT- MEDLINE
DCOM- 20140828
LR  - 20211021
IS  - 1569-9285 (Electronic)
IS  - 1569-9293 (Print)
IS  - 1569-9285 (Linking)
VI  - 18
IP  - 1
DP  - 2014 Jan
TI  - Long-term follow-up after autologous skeletal myoblast transplantation in 
      ischaemic heart disease.
PG  - 61-6
LID - 10.1093/icvts/ivt434 [doi]
AB  - OBJECTIVES: Short-term follow-up after autologous skeletal myoblasts (ASM) 
      transplantation (Tx) (Myoblast Autologous Grafting in Ischaemic Cardiomyopathy 
      (MAGIC) Phase II Study) for the treatment of ischaemic cardiomyopathy revealed 
      improved left ventricular (LV) remodelling. Our study reports the longest 
      long-term worldwide follow-up of a single-centre cohort, focusing on the safety 
      and efficacy of ASM-Tx. METHODS: The multicentre MAGIC Phase II Study involved 
      120 patients and was conducted between 2004 and 2006. Out of the 120 patients 
      involved in the entire study, the cohort treated at our institution contained 7 
      patients only. These 7 patients received ASM-Tx (injection volume: 400 million 
      cells, n = 2 low dosage; 800 million cells, n = 2 high dosage) or placebo (n = 3) 
      injections, in addition to coronary artery bypass grafting (CABG). After closure 
      of the MAGIC registry, we conducted a long-term follow-up for our 7-patient 
      cohort. The mean follow-up was 72.0 +/- 5.3 months. The follow-up was complete for 
      echo data, implanted cardioverter defibrillator (ICD) report, clinical 
      investigation and New York Heart Association (NYHA) class. RESULTS: At final 
      follow-up, all the patients were alive, and 5 were in NYHA class 1 or 2. There 
      were 6 hospitalizations for congestive heart failure during the follow-up (1 
      patient from each group). One patient (placebo group) was treated twice for 
      ventricular fibrillation by the ICD. The LV ejection fraction remained stable in 
      all the three groups (31.1 +/- 3.9% preoperative vs 29.4 +/- 4.4% at final 
      follow-up). The LV volumes were reduced in the high-dosage group, remained 
      unchanged in the low-dosage group and deteriorated in the placebo group. 
      CONCLUSIONS: Our long-term data confirm the findings of the MAGIC study. The LV 
      function did not improve, but the long-term LV volumes in the high-dosage group 
      were reduced. During the follow-up, there were also no additional arrhythmogenic 
      incidences. Our data could imply that CABG in combination with ASM-Tx is safe and 
      has beneficial therapeutic effects in the long-term. However, due to the small 
      patient number, the clinical impact is limited.
FAU - Brickwedel, Jens
AU  - Brickwedel J
AD  - Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, 
      Germany.
FAU - Gulbins, Helmut
AU  - Gulbins H
FAU - Reichenspurner, Hermann
AU  - Reichenspurner H
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20131014
PL  - England
TA  - Interact Cardiovasc Thorac Surg
JT  - Interactive cardiovascular and thoracic surgery
JID - 101158399
SB  - IM
MH  - Aged
MH  - Coronary Artery Bypass
MH  - Defibrillators, Implantable
MH  - Double-Blind Method
MH  - Electric Countershock/instrumentation
MH  - Germany
MH  - Heart Failure/etiology/physiopathology/therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myoblasts, Skeletal/*transplantation
MH  - Myocardial Ischemia/complications/pathology/physiopathology/*surgery
MH  - Myocardium/*pathology
MH  - Patient Readmission
MH  - Prospective Studies
MH  - Recovery of Function
MH  - *Regeneration
MH  - Registries
MH  - *Stem Cell Transplantation/adverse effects
MH  - Stroke Volume
MH  - Time Factors
MH  - Transplantation, Autologous
MH  - Treatment Outcome
MH  - Ventricular Fibrillation/etiology/physiopathology/therapy
MH  - Ventricular Function, Left
PMC - PMC3867044
OTO - NOTNLM
OT  - Cardiac cell therapy
OT  - Chronic ischaemic heart disease
OT  - Long-term follow-up
EDAT- 2013/10/17 06:00
MHDA- 2014/08/29 06:00
PMCR- 2015/01/01
CRDT- 2013/10/17 06:00
PHST- 2013/10/17 06:00 [entrez]
PHST- 2013/10/17 06:00 [pubmed]
PHST- 2014/08/29 06:00 [medline]
PHST- 2015/01/01 00:00 [pmc-release]
AID - ivt434 [pii]
AID - 10.1093/icvts/ivt434 [doi]
PST - ppublish
SO  - Interact Cardiovasc Thorac Surg. 2014 Jan;18(1):61-6. doi: 10.1093/icvts/ivt434. 
      Epub 2013 Oct 14.