Long-term follow-up after autologous skeletal myoblast transplantation in ischaemic heart disease
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Long-term follow-up after autologous skeletal myoblast transplantation in ischaemic heart disease. / Brickwedel, Jens; Gulbins, Helmut; Reichenspurner, Hermann.
In: INTERACT CARDIOV TH, Vol. 18, No. 1, 01.2014, p. 61-66.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Long-term follow-up after autologous skeletal myoblast transplantation in ischaemic heart disease
AU - Brickwedel, Jens
AU - Gulbins, Helmut
AU - Reichenspurner, Hermann
PY - 2014/1
Y1 - 2014/1
N2 - 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.
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.
KW - Aged
KW - Coronary Artery Bypass
KW - Defibrillators, Implantable
KW - Double-Blind Method
KW - Electric Countershock/instrumentation
KW - Germany
KW - Heart Failure/etiology
KW - Humans
KW - Male
KW - Middle Aged
KW - Myoblasts, Skeletal/transplantation
KW - Myocardial Ischemia/complications
KW - Myocardium/pathology
KW - Patient Readmission
KW - Prospective Studies
KW - Recovery of Function
KW - Regeneration
KW - Registries
KW - Stem Cell Transplantation/adverse effects
KW - Stroke Volume
KW - Time Factors
KW - Transplantation, Autologous
KW - Treatment Outcome
KW - Ventricular Fibrillation/etiology
KW - Ventricular Function, Left
U2 - 10.1093/icvts/ivt434
DO - 10.1093/icvts/ivt434
M3 - SCORING: Journal article
C2 - 24130088
VL - 18
SP - 61
EP - 66
JO - INTERACT CARDIOV TH
JF - INTERACT CARDIOV TH
SN - 1569-9293
IS - 1
ER -
