title: Transendocardial autologous bone marrow in chronic myocardial infarction using a helical needle catheter: 1-year follow-up in an open-label, nonrandomized, single-center pilot study (the TABMMI study).
abstract: BACKGROUND
  Cell therapy has shown benefit in preclinical and clinical studies, although debate continues on the mechanism of action and the most appropriate methods for performing such therapies. We assessed the hypothesis that helical needle transendocardial (TE) delivery of autologous bone marrow (ABM) mononuclear cells around regions of hypo- or akinesia in patients after chronic myocardial infarction (MI) would be safe and possibly improve ejection fraction (EF).
  
  
  RESULTS
  Ten stable post-MI patients with an EF <40% were enrolled. Autologous bone marrow cells were aspirated from the iliac crest and delivered percutaneously with a TE helical needle catheter. A total of 86 x 10(6) cells were injected into 7.1 +/- 3.1 sites around the infarct to target the peri-infarct zones. Two-dimensional echocardiographic left ventricle EF measurements, 24-hour Holter, and exercise tolerance testing were performed at baseline, day of procedure, 1 and 12 weeks, and 6 and 12 months. There were no adverse events associated with the catheter-based cell transplantation procedure. At 6 and 12 months, all patients showed an improvement in left ventricle EF over baseline (35.2 +/- 4.6 to 40.8 +/- 4.5, P = .003 at 6 months; 35.2 +/- 4.6 to 42.3 +/- 5.1, P = .0001 at 12 months).
  
  
  CONCLUSIONS
  Autologous bone marrow cells delivered with the helical needle TE catheter was safe in this small uncontrolled study in patients with chronic MI. Increased EF and other positive data trends support continued development of this therapeutic strategy in larger controlled trials.
authors.affiliation: Interventional Cardiology, Argentine Institute of Diagnosis and Treatment and Swiss Clinic, Buenos Aires, Argentina.
authors.forename: Luis M
authors.initials: LM
authors.lastname: de la Fuente
authors.forename: Simon H
authors.initials: SH
authors.lastname: Stertzer
authors.forename: Julio
authors.initials: J
authors.lastname: Argentieri
authors.forename: Eduardo
authors.initials: E
authors.lastname: Peñaloza
authors.forename: Jorge
authors.initials: J
authors.lastname: Miano
authors.forename: Benjamin
authors.initials: B
authors.lastname: Koziner
authors.forename: Cristian
authors.initials: C
authors.lastname: Bilos
authors.forename: Peter A
authors.initials: PA
authors.lastname: Altman
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000209:etiology; D016026:Bone Marrow Transplantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D002404:Catheterization; D002908:Chronic Disease; D005080:Exercise Test; D017079:Exercise Tolerance; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D009339:Needles; D010865:Pilot Projects; D014182:Transplantation, Autologous / Q000295:instrumentation / Q000379:methods