title: Long-term follow-up after autologous skeletal myoblast transplantation in ischaemic heart disease.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Brickwedel
authors.forename: Helmut
authors.initials: H
authors.lastname: Gulbins
authors.forename: Hermann
authors.initials: H
authors.lastname: Reichenspurner
mesh_terms: D000368:Aged; D001026:Coronary Artery Bypass; D017147:Defibrillators, Implantable; D004311:Double-Blind Method; D004554:Electric Countershock / Q000295:instrumentation; D005858:Germany; D006333:Heart Failure / Q000209:etiology / Q000503:physiopathology / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D032448:Myoblasts, Skeletal / Q000637:transplantation*; D017202:Myocardial Ischemia / Q000150:complications / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D009206:Myocardium / Q000473:pathology*; D010359:Patient Readmission; D011446:Prospective Studies; D020127:Recovery of Function; D012038:Regeneration; D012042:Registries; D033581:Stem Cell Transplantation / Q000009:adverse effects; D013318:Stroke Volume; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000209:etiology / Q000503:physiopathology / Q000628:therapy; D016277:Ventricular Function, Left
keywords: Cardiac cell therapy; Chronic ischaemic heart disease; Long-term follow-up