title: Randomized, double-blind, phase I/II study of intravenous allogeneic mesenchymal stromal cells in acute myocardial infarction.
abstract: OBJECTIVE
  Cell therapy is promising as an exploratory cardiovascular therapy. We have recently developed an investigational new drug named Stempeucel (bone marrow-derived allogeneic mesenchymal stromal cells) for patients with acute myocardial infarction (AMI) with ST-segment elevation. A phase I/II randomized, double-blind, single-dose study was conducted to assess the safety and efficacy of intravenous administration of Stempeucel versus placebo (multiple electrolytes injection).
  
  
  METHODS
  Twenty patients who had undergone percutaneous coronary intervention for AMI were randomly assigned (1:1) to receive intravenous Stempeucel or placebo and were followed for 2 years.
  
  
  RESULTS
  The number of treatment-emergent adverse events observed were 18 and 21 in the Stempeucel and placebo groups, respectively. None of the adverse events were related to Stempeucel according to the investigators and independent data safety monitoring board. There was no serious adverse event in the Stempeucel group and there were three serious adverse events in the placebo group, of which one had a fatal outcome. Ejection fraction determined by use of echocardiography showed improvement in both Stempeucel (43.06% to 47.80%) and placebo (43.44% to 45.33%) groups at 6 months (P = 0.26). Perfusion scores measured by use of single-photon emission tomography and infarct volume measured by use of magnetic resonance imaging showed no significant differences between the two groups at 6 months.
  
  
  CONCLUSIONS
  This study showed that Stempeucel was safe and well tolerated when administered intravenously in AMI patients 2 days after percutaneous coronary intervention. The optimal dose and route of administration needs further evaluation in larger clinical trials (http://clinicaltrials.gov/show/NCT00883727).
authors.affiliation: Stempeutics Research Pvt Ltd, Bangalore, India, and Stempeutics Research Manipal, India.
authors.forename: Anoop
authors.initials: A
authors.lastname: Chullikana
authors.affiliation: Stempeutics Research Pvt Ltd, Bangalore, India, and Stempeutics Research Manipal, India.
authors.forename: Anish Sen
authors.initials: AS
authors.lastname: Majumdar
authors.affiliation: Stempeutics Research Pvt Ltd, Bangalore, India, and Stempeutics Research Manipal, India.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Gottipamula
authors.affiliation: Stempeutics Research Pvt Ltd, Bangalore, India, and Stempeutics Research Manipal, India.
authors.forename: Sagar
authors.initials: S
authors.lastname: Krishnamurthy
authors.affiliation: CARE Hospital Hyderabad, India.
authors.forename: A Sreenivas
authors.initials: AS
authors.lastname: Kumar
authors.affiliation: M.S. Ramaiah Hospital Bangalore, India.
authors.forename: V S
authors.initials: VS
authors.lastname: Prakash
authors.affiliation: M.S. Ramaiah Hospital Bangalore, India. Electronic address: pawan.gupta@stempeutics.com.
authors.forename: Pawan Kumar
authors.initials: PK
authors.lastname: Gupta
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D001854:Bone Marrow Cells / Q000166:cytology; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D010919:Placebos; D055815:Young Adult
chemical_list: D010919:Placebos
keywords: acute myocardial infarction; bone marrow; cell therapy; mesenchymal stromal cells