title: Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies.
abstract: BACKGROUND
  Apart from haematopoietic stem cell transplantation for haematological disorders many stem cell-based therapies are experimental. However, with only 12 years between human embryonic stem cell isolation and the first clinical trial, development of stem cell products for regenerative medicine has been rapid and numerous clinical trials have begun to investigate their therapeutic potential.
  
  
  METHODS
  This review summarizes key clinical trial data, current and future perspectives on stem cell-based products undergoing clinical trials, based on literature search and author research.
  
  
  RESULTS
  It is widely recognized that the ability to stimulate stem cell differentiation into specialized cells for use as cellular therapies will revolutionize health care and offer major hope for numerous diseases for which there are limited or no therapeutic options.
  
  
  RESULTS
  Stem cell-based products are unique and cover a large range of disorders to be treated; therefore, there is significant potential for variation in cell source, type, processing manipulation, the bioprocessing approach and scalability, the cost and purity of manufacture, final product quality and mode of action. As such there are gaps in regulatory and manufacturing frameworks and technologies, only a small number of products are currently within late phase clinical trials and few products have achieved commercialization.
  
  
  CONCLUSIONS
  Recent developments are encouraging acceleration through the difficulties encountered en route to clinical trials and commercialization of stem cell therapies.
  
  
  CONCLUSIONS
  The field is growing year on year with the first clinical trial using induced pluripotent stem cells anticipated by end 2013.
authors.affiliation: Healthcare Engineering Research Group, Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University, Loughborough, Leicestershire LE11 3TU, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ratcliffe
authors.forename: Katie E
authors.initials: KE
authors.lastname: Glen
authors.forename: May Win
authors.initials: MW
authors.lastname: Naing
authors.forename: David J
authors.initials: DJ
authors.lastname: Williams
mesh_terms: D000818:Animals; D002454:Cell Differentiation / Q000502:physiology; D005060:Europe; D015316:Genetic Therapy / Q000379:methods; D006801:Humans; D057026:Induced Pluripotent Stem Cells / Q000502:physiology; D007564:Japan; D044968:Regenerative Medicine / Q000639:trends*; D033581:Stem Cell Transplantation / Q000639:trends*; D014481:United States
keywords: clinical trial; commercialisation; regenerative medicine; regulation; stem cell-based therapy