title: Myocardial Assistance by Grafting a New Bioartificial Upgraded Myocardium (MAGNUM trial): clinical feasibility study.
abstract: BACKGROUND
  Cell transplantation for the regeneration of ischemic myocardium is limited by poor graft viability and low cell retention. In ischemic cardiomyopathy, the extracellular matrix is deeply altered; therefore, it could be important to associate a procedure aiming at regenerating myocardial cells and restoring the extracellular matrix function. We evaluated the feasibility and safety of intrainfarct cell therapy associated with a cell-seeded collagen scaffold grafted onto infarcted ventricles.
  
  
  METHODS
  In 20 consecutive patients presenting with left ventricular postischemic myocardial scars and indication for coronary artery bypass graft surgery, bone marrow cells were implanted during surgery. In the last 10 patients, we added a collagen matrix seeded with bone marrow cells, placed onto the scar.
  
  
  RESULTS
  There was no mortality and any related adverse events (follow-up 10 +/- 3.5 months). New York Heart Association functional class improved in both groups from 2.3 +/- 0.5 to 1.3 +/- 0.5 (matrix, p = 0.0002) versus 2.4 +/- 0.5 to 1.5 +/- 0.5 (no matrix, p = 0.001). Left ventricular end-diastolic volume evolved from 142.4 +/- 24.5 mL to 112.9 +/- 27.3 mL (matrix, p = 0.02) versus 138.9 +/- 36.1 mL to 148.7 +/- 41 mL (no matrix, p = 0.57), left ventricular filling deceleration time improved significantly in the matrix group from 162 +/- 7 ms to 198 +/- 9 ms (p = 0.01) versus the no-matrix group (from 159 +/- 5 ms to 167 +/- 8 ms, p = 0.07). Scar area thickness progressed from 6 +/- 1.4 to 9 mm +/- 1.1 mm (matrix, p = 0.005) versus 5 +/- 1.5 mm to 6 +/- 0.8 mm (no matrix, p = 0.09). Ejection fraction improved in both groups, from 25.3% +/- 7.3% to 32% +/- 5.4% (matrix, p = 0.03) versus 27.2% +/- 6.9% to 34.6% +/- 7.3% (no matrix, p = 0.031).
  
  
  CONCLUSIONS
  This tissue-engineered approach is feasible and safe and appears to improve the efficiency of cellular cardiomyoplasty. The cell-seeded collagen matrix increases the thickness of the infarct scar with viable tissue and helps to normalize cardiac wall stress in injured regions, thus limiting ventricular remodeling and improving diastolic function.
authors.affiliation: Department of Cardiovascular Surgery, Pompidou Hospital, Paris, France. j.chachques@brs.aphp.fr
authors.forename: Juan C
authors.initials: JC
authors.lastname: Chachques
authors.forename: Jorge C
authors.initials: JC
authors.lastname: Trainini
authors.forename: Noemi
authors.initials: N
authors.lastname: Lago
authors.forename: Miguel
authors.initials: M
authors.lastname: Cortes-Morichetti
authors.forename: Olivier
authors.initials: O
authors.lastname: Schussler
authors.forename: Alain
authors.initials: A
authors.lastname: Carpentier
mesh_terms: D020341:Absorbable Implants; D016026:Bone Marrow Transplantation; D006348:Cardiac Surgical Procedures / Q000379:methods; D024042:Collagen Type I; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000601:surgery*; D054457:Tissue Scaffolds
chemical_list: D024042:Collagen Type I