title: Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase-bright stem cells in patients with ischemic heart failure.
abstract: BACKGROUND
  The optimal type of stem cell for use in patients with ischemic heart disease has not been determined. A primitive population of bone marrow-derived hematopoietic cells has been isolated by the presence of the enzyme aldehyde dehydrogenase and comprises a multilineage mix of stem and progenitor cells. Aldehyde dehydrogenase-bright (ALDH(br)) cells have shown promise in promoting angiogenesis and providing perfusion benefits in preclinical ischemia studies. We hypothesize that ALDH(br) cells may be beneficial in treating ischemic heart disease and thus conducted the first randomized, controlled, double-blind study to assess the safety of the transendocardial injection of autologous ALDH(br) cells isolated from the bone marrow in patients with advanced ischemic heart failure.
  
  
  METHODS
  Aldehyde dehydrogenase-bright cells were isolated from patients' bone marrow on the basis of the expression of a functional (aldehyde dehydrogenase) marker. We enrolled 20 patients (treatment, n = 10; control, n = 10). Safety (primary end point) and efficacy (secondary end point) were assessed at 6 months.
  
  
  RESULTS
  No major adverse cardiovascular or cerebrovascular events occurred in ALDH(br)-treated patients in the periprocedural period (up to 1 month); electromechanical mapping-related ventricular tachycardia (n = 2) and fibrillation (n = 1) occurred in control patients. Aldehyde dehydrogenase-bright-treated patients showed a significant decrease in left ventricular end-systolic volume at 6 months (P = .04) and a trend toward improved maximal oxygen consumption. The single photon emission computed tomography delta analysis showed a trend toward significant improvement in reversibility in cell-treated patients (P = .053).
  
  
  CONCLUSIONS
  We provide preliminary evidence that treatment with the novel cell population, ALDH(br) cells, is safe and may provide perfusion and functional benefits in patients with chronic myocardial ischemia.
authors.affiliation: Stem Cell Center at the Texas Heart Institute at St Luke's Episcopal Hospital, Houston, TX, USA. eperin@bluegate.com
authors.forename: Emerson C
authors.initials: EC
authors.lastname: Perin
authors.forename: Guilherme V
authors.initials: GV
authors.lastname: Silva
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.forename: Amir
authors.initials: A
authors.lastname: Gahremanpour
authors.forename: John
authors.initials: J
authors.lastname: Canales
authors.forename: Dipsu
authors.initials: D
authors.lastname: Patel
authors.forename: Marlos R
authors.initials: MR
authors.lastname: Fernandes
authors.forename: Laurence H
authors.initials: LH
authors.lastname: Keller
authors.forename: Xin
authors.initials: X
authors.lastname: Quan
authors.forename: Stephanie A
authors.initials: SA
authors.lastname: Coulter
authors.forename: Warren H
authors.initials: WH
authors.lastname: Moore
authors.forename: J Patrick
authors.initials: JP
authors.lastname: Herlihy
authors.forename: James T
authors.initials: JT
authors.lastname: Willerson
mesh_terms: D000444:Aldehyde Dehydrogenase / Q000494:pharmacology*; D018780:Body Surface Potential Mapping; D004311:Double-Blind Method; D004699:Endocardium; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D010865:Pilot Projects; D033581:Stem Cell Transplantation / Q000379:methods*; D015899:Tomography, Emission-Computed, Single-Photon; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D000444:Aldehyde Dehydrogenase