title: Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial.
abstract: OBJECTIVE
  Adipose-derived regenerative cells (ADRCs) can be isolated from liposuction aspirates and prepared as fresh cells for immediate administration in cell therapy. We performed the first randomized, placebo-controlled, double-blind trial to examine the safety and feasibility of the transendocardial injections of ADRCs in no-option patients with ischemic cardiomyopathy.
  
  
  RESULTS
  Procedural, postoperative, and follow-up safety end points were monitored up to 36 months. After baseline measurements, efficacy was assessed by echocardiography and single-photon emission computed tomography (6, 12, and 18 months), metabolic equivalents and maximal oxygen consumption (MVO2) (6 and 18 months), and cardiac magnetic resonance imaging (6 months). We enrolled 21 ADRC-treated and 6 control patients. Liposuction was well tolerated, ADRCs were successfully prepared, and transendocardial injections were feasible in all patients. No malignant arrhythmias were seen. Adverse events were similar between groups. Metabolic equivalents and MVO2 values were preserved over time in ADRC-treated patients but declined significantly in the control group. The difference in the change in MVO2 from baseline to 6 and 18 months was significantly better in ADRC-treated patients compared with controls. The ADRC-treated patients showed significant improvements in total left ventricular mass by magnetic resonance imaging and wall motion score index. Single-photon emission computed tomography results suggested a reduction in inducible ischemia in ADRC-treated patients up to 18 months.
  
  
  CONCLUSIONS
  Isolation and transendocardial injection of autologous ADRCs in no-option patients were safe and feasible. Our results suggest that ADRCs may preserve ventricular function, myocardial perfusion, and exercise capacity in these patients.
authors: Stem Cell Center, Texas Heart Institute, Houston, TX.
authors: Emerson C
authors: EC
authors: Perin
authors: Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors: Ricardo
authors: R
authors: Sanz-Ruiz
authors: Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors: Pedro L
authors: PL
authors: Sánchez
authors: Plastic Surgery Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors: José
authors: J
authors: Lasso
authors: Plastic Surgery Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors: Rosa
authors: R
authors: Pérez-Cano
authors: Nuclear Medicine Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors: Juan C
authors: JC
authors: Alonso-Farto
authors: Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors: Esther
authors: E
authors: Pérez-David
authors: Cell Production Unit, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors: Maria Eugenia
authors: ME
authors: Fernández-Santos
authors: Department of Interventional Cardiology, Thoraxcenter, Rotterdam, Utrecht, The Netherlands.
authors: Patrick W
authors: PW
authors: Serruys
authors: Department of Interventional Cardiology, Thoraxcenter, Rotterdam, Utrecht, The Netherlands.
authors: Henrick J
authors: HJ
authors: Duckers
authors: Cardiology Department, Rigshospitalet University Hospital, Copenhagen, Denmark.
authors: Jens
authors: J
authors: Kastrup
authors: Cardiology Department, University of Utrecht Medical Center, Utrecht, The Netherlands.
authors: Steven
authors: S
authors: Chamuleau
authors: Stem Cell Center, Texas Heart Institute, Houston, TX.
authors: Yi
authors: Y
authors: Zheng
authors: Stem Cell Center, Texas Heart Institute, Houston, TX.
authors: Guilherme V
authors: GV
authors: Silva
authors: Stem Cell Center, Texas Heart Institute, Houston, TX.
authors: James T
authors: JT
authors: Willerson
authors: Cardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain. Electronic address: faviles@secardiologia.es.
authors: Francisco
authors: F
authors: Fernández-Avilés
mesh_terms: D017667:Adipocytes / Q000637:transplantation*; D000368:Aged; D017690:Cell Transplantation / Q000379:methods*; D003114:Colony-Forming Units Assay; D004311:Double-Blind Method; D004562:Electrocardiography; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D019028:Magnetic Resonance Imaging, Cine; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000473:pathology* / Q000628:therapy; D011446:Prospective Studies; D014182:Transplantation, Autologous; D016896:Treatment Outcome