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J Am Coll Cardiol, 2003; 41:1078-1083, doi:10.1016/S0735-1097(03)00092-5
© 2003 by the American College of Cardiology Foundation
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CLINICAL STUDY

Autologous skeletal myoblast transplantation for severe postinfarction left ventricular dysfunction

Philippe Menasché, MD, PhD*,*, Albert A. Hagège, MD, PhD{dagger}, Jean-Thomas Vilquin, PhD{ddagger}, Michel Desnos, MD{dagger}, Eric Abergel, MD{dagger}, Bruno Pouzet, MD*, Alain Bel, MD*, Sorin Sarateanu, MD*, Marcio Scorsin, MD, PhD*, Ketty Schwartz, PhD{ddagger}, Patrick Bruneval, MD§, Marc Benbunan, MD||, Jean-Pierre Marolleau, MD|| and Denis Duboc, MD

* Assistance Publique-Hôpitaux de Paris, Department of Cardiovascular Surgery B, Hôpital Bichat, Paris, France
{dagger} Department of Cardiology, Hôpital Européen Georges Pompidou and INSERM EMI 00-16, Faculté de Médecine Necker Enfants-Malades, Paris V University, Paris, France
{ddagger} INSERM U 582, Groupe Hospitalier Pitié Salpêtrière, Paris, France
§ Department of Pathology, Hôpital Européen Georges Pompidou, Paris, France
|| Laboratory of Cell Therapy, Hôpital Saint Louis, Paris, France
Department of Cardiology, Hôpital Cochin, Paris V University, Paris, and Department of Nuclear Medicine Frédéric Joliot, Commissariat à l’Energie Atomique, Orsay, France

Manuscript received June 11, 2002; revised manuscript received October 2, 2002, accepted October 17, 2002.

* Reprint requests and correspondence: Dr. Philippe Menasché, Département de Chirurgie Cardiovasculaire, Hôpital Européen Georges Pompidou, 20 rue Leblanc, 75015 Paris, France.
philippe.menasche{at}hop.egp.ap-hop-paris.fr

OBJECTIVES: This phase I trial was designed to assess the feasibility and safety of autologous skeletal myoblast transplantation in patients with severe ischemic cardiomyopathy.

BACKGROUND: Experimentally, myoblast grafting into postinfarction myocardial scars improves left ventricular function.

METHODS: Ten patients were included on the basis of the following criteria: 1) severe left ventricular dysfunction (ejection fraction ≤35%); 2) the presence of a postinfarction akinetic and nonviable scar, as assessed by dobutamine echocardiography and 18-fluorodeoxyglucose positron emission tomography; and 3) an indication of coronary bypass in remote areas. Skeletal myoblasts were grown from a biopsy taken at the thigh.

RESULTS: An average of 871 x 106 cells (86% of myoblasts) were obtained after a mean period of 16 days and implanted uneventfully across the scar at the time of bypass. Except for one patient whose early death was unrelated to the cell transplantation, all patients had an uncomplicated postoperative course. Four patients showed delayed episodes of sustained ventricular tachycardia and were implanted with an internal defibrillator. At an average follow-up of 10.9 months, the mean New York Heart Association functional class improved from 2.7 ± 0.2 preoperatively to 1.6 ± 0.1 postoperatively (p < 0.0001), and the ejection fraction increased from 24 ± 1% to 32 ± 1% (p < 0.02). A blinded echocardiographic analysis showed that 63% of the cell-implanted scars (14 of 22) demonstrated improved systolic thickening. One noncardiac death occurred 17.5 months after transplantation.

CONCLUSIONS: These preliminary data suggest the feasibility and safety of autologous skeletal myoblast transplantation in severe ischemic cardiomyopathy, with the caveat of an arrhythmogenic potential. New-onset contraction of akinetic and nonviable segments suggests a functional efficacy that requires confirmation by randomized studies.

Abbreviations and Acronyms
  AICD = automatic internal cardioverter-defibrillator
  CABG = coronary artery bypass graft
  18FDG = fluorine-18–labeled fluorodeoxyglucose
  LV = left ventricle/ventricular
  LVEDV = left ventricular end-diastolic volume
  LVEF = left ventricular ejection fraction
  LVESV = left ventricular end-systolic volume
  NYHA = New York Heart Association
  PET = positron emission tomography
  VT = ventricular tachycardia




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O. Caspi and L. Gepstein
Stem cells for myocardial repair
Eur. Heart J. Suppl., September 1, 2006; 8(suppl_E): E43 - E54.
[Abstract] [Full Text] [PDF]

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 Cardiovasc ResHome page
T. P. de Boer, M. A.G. van der Heyden, M. B. Rook, R. Wilders, R. Broekstra, B. Kok, M. A. Vos, J. M.T. de Bakker, and T. A.B. van Veen
Pro-arrhythmogenic potential of immature cardiomyocytes is triggered by low coupling and cluster size
Cardiovasc Res, September 1, 2006; 71(4): 704 - 714.
[Abstract] [Full Text] [PDF]

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 Cardiovasc ResHome page
J. J. Gavira, M. Perez-Ilzarbe, G. Abizanda, A. Garcia-Rodriguez, J. Orbe, J. A. Paramo, M. Belzunce, G. Rabago, J. Barba, J. Herreros, et al.
A comparison between percutaneous and surgical transplantation of autologous skeletal myoblasts in a swine model of chronic myocardial infarction
Cardiovasc Res, September 1, 2006; 71(4): 744 - 753.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
T. P. Martens, M. Argenziano, and M. C. Oz
New Technology for Surgical Coronary Revascularization
Circulation, August 8, 2006; 114(6): 606 - 614.
[Full Text] [PDF]

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 CirculationHome page
A. J. Boyle, S. P. Schulman, and J. M. Hare
Stem Cell Therapy for Cardiac Repair: Ready for the Next Step
Circulation, July 25, 2006; 114(4): 339 - 352.
[Full Text] [PDF]

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 CirculationHome page
P. Oettgen
Cardiac Stem Cell Therapy: Need for Optimization of Efficacy and Safety Monitoring
Circulation, July 25, 2006; 114(4): 353 - 358.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
T. A.B. van Veen, J. M.T. de Bakker, and M. A.G. van der Heyden
Mesenchymal Stem Cells Repair Conduction Block
J. Am. Coll. Cardiol., July 4, 2006; 48(1): 219 - 220.
[Full Text] [PDF]

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 CirculationHome page
M. Hendrikx, K. Hensen, C. Clijsters, H. Jongen, R. Koninckx, E. Bijnens, M. Ingels, A. Jacobs, R. Geukens, P. Dendale, et al.
Recovery of Regional but Not Global Contractile Function by the Direct Intramyocardial Autologous Bone Marrow Transplantation: Results From a Randomized Controlled Clinical Trial
Circulation, July 4, 2006; 114(1_suppl): I-101 - I-107.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
A. A. Hagege, J.-P. Marolleau, J.-T. Vilquin, A. Alheritiere, S. Peyrard, D. Duboc, E. Abergel, E. Messas, E. Mousseaux, K. Schwartz, et al.
Skeletal Myoblast Transplantation in Ischemic Heart Failure: Long-Term Follow-Up of the First Phase I Cohort of Patients
Circulation, July 4, 2006; 114(1_suppl): I-108 - I-113.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
L.C. Guarita-Souza, K.A.T. Carvalho, V. Woitowicz, C. Rebelatto, A. Senegaglia, P. Hansen, N. Miyague, J.C. Francisco, M. Olandoski, J.R. Faria-Neto, et al.
Simultaneous Autologous Transplantation of Cocultured Mesenchymal Stem Cells and Skeletal Myoblasts Improves Ventricular Function in a Murine Model of Chagas Disease
Circulation, July 4, 2006; 114(1_suppl): I-120 - I-124.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
S. A. Taheri
Use of autologous adult stem cell for treatment of congestive heart failure
J. Thorac. Cardiovasc. Surg., July 1, 2006; 132(1): 214 - 214.
[Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
J. Y. Kresh
Cell replacement therapy: The functional importance of myocardial architecture and intercellular gap-junction distribution
J. Thorac. Cardiovasc. Surg., June 1, 2006; 131(6): 1310 - 1313.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
C. E. Murry, H. Reinecke, and L. M. Pabon
Regeneration Gaps: Observations on Stem Cells and Cardiac Repair
J. Am. Coll. Cardiol., May 2, 2006; 47(9): 1777 - 1785.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
P. W. Serruys
Fourth Annual American College of Cardiology International Lecture: A Journey in the Interventional Field
J. Am. Coll. Cardiol., May 2, 2006; 47(9): 1754 - 1768.
[Full Text] [PDF]

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 CirculationHome page
M. G. Chang, L. Tung, R. B. Sekar, C. Y. Chang, J. Cysyk, P. Dong, E. Marban, and M. R. Abraham
Proarrhythmic Potential of Mesenchymal Stem Cell Transplantation Revealed in an In Vitro Coculture Model
Circulation, April 18, 2006; 113(15): 1832 - 1841.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
J. J. Gavira, J. Herreros, A. Perez, M. J. Garcia-Velloso, J. Barba, F. Martin-Herrero, C. Canizo, A. Martin-Arnau, J. M. Marti-Climent, M. Hernandez, et al.
Autologous skeletal myoblast transplantation in patients with nonacute myocardial infarction: 1-year follow-up
J. Thorac. Cardiovasc. Surg., April 1, 2006; 131(4): 799 - 804.
[Abstract] [Full Text] [PDF]

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 Circ. Res.Home page
A. Furuta, S. Miyoshi, Y. Itabashi, T. Shimizu, S. Kira, K. Hayakawa, N. Nishiyama, K. Tanimoto, Y. Hagiwara, T. Satoh, et al.
Pulsatile Cardiac Tissue Grafts Using a Novel Three-Dimensional Cell Sheet Manipulation Technique Functionally Integrates With the Host Heart, In Vivo
Circ. Res., March 17, 2006; 98(5): 705 - 712.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
F. G.P. Welt and D. W. Losordo
Cell Therapy for Acute Myocardial Infarction: Curb Your Enthusiasm?
Circulation, March 14, 2006; 113(10): 1272 - 1274.
[Full Text] [PDF]

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 Physiol. GenomicsHome page
J. C. Wu, J. M. Spin, F. Cao, S. Lin, X. Xie, O. Gheysens, I. Y. Chen, A. Y. Sheikh, R. C. Robbins, A. Tsalenko, et al.
Transcriptional profiling of reporter genes used for molecular imaging of embryonic stem cell transplantation
Physiol Genomics, March 13, 2006; 25(1): 29 - 38.
[Abstract] [Full Text] [PDF]

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 Cardiovasc ResHome page
T. M. Kolettis
Arrhythmogenesis after cell transplantation post-myocardial infarction. Four burning questions-And some answers
Cardiovasc Res, February 1, 2006; 69(2): 299 - 301.
[Full Text] [PDF]

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 Cardiovasc ResHome page
S. Fernandes, J.-C. Amirault, G. Lande, J.-M. Nguyen, V. Forest, O. Bignolais, G. Lamirault, D. Heudes, J.-L. Orsonneau, M.-F. Heymann, et al.
Autologous myoblast transplantation after myocardial infarction increases the inducibility of ventricular arrhythmias
Cardiovasc Res, February 1, 2006; 69(2): 348 - 358.
[Abstract] [Full Text] [PDF]

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 JEMHome page
M. T. Kuhlmann, P. Kirchhof, R. Klocke, L. Hasib, J. Stypmann, L. Fabritz, M. Stelljes, W. Tian, M. Zwiener, M. Mueller, et al.
G-CSF/SCF reduces inducible arrhythmias in the infarcted heart potentially via increased connexin43 expression and arteriogenesis
J. Exp. Med., January 23, 2006; 203(1): 87 - 97.
[Abstract] [Full Text] [PDF]


 
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