title: The Alpha Stem Cell Clinic: a model for evaluating and delivering stem cell-based therapies.
abstract: Cellular therapies require the careful preparation, expansion, characterization, and delivery of cells in a clinical environment. There are major challenges associated with the delivery of cell therapies and high costs that will limit the companies available to fully evaluate their merit in clinical trials, and will handicap their application at the present financial environment. Cells will be manufactured in good manufacturing practice or near-equivalent facilities with prerequisite safety practices in place, and cell delivery systems will be specialized and require well-trained medical and nursing staff, technicians or nurses trained to handle cells once delivered, patient counselors, as well as statisticians and database managers who will oversee the monitoring of patients in relatively long-term follow-up studies. The model proposed for Alpha Stem Cell Clinics will initially use the capacities and infrastructure that exist in the most advanced tertiary medical clinics for delivery of established bone marrow stem cell therapies. As the research evolves, they will incorporate improved procedures and cell preparations. This model enables commercialization of medical devices, reagents, and other products required for cell therapies. A carefully constructed cell therapy clinical infrastructure with the requisite scientific, technical, and medical expertise and operational efficiencies will have the capabilities to address three fundamental and critical functions: 1) fostering clinical trials; 2) evaluating and establishing safe and effective therapies, and 3) developing and maintaining the delivery of therapies approved by the Food and Drug Administration, or other regulatory agencies.
authors.affiliation: California Institute for Regenerative Medicine (CIRM), 210 King Street, San Francisco, California 94107, USA. atrounson@cirm.ca.gov
authors.forename: Alan
authors.initials: A
authors.lastname: Trounson
authors.forename: Natalie D
authors.initials: ND
authors.lastname: DeWitt
authors.forename: Ellen G
authors.initials: EG
authors.lastname: Feigal
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000191:economics / Q000458:organization & administration*; D003299:Cooperative Behavior; D019981:Health Care Sector / Q000458:organization & administration; D006268:Health Facilities; D058016:Health Facility Administration / Q000191:economics; D006801:Humans; D007373:Interinstitutional Relations; D017146:Models, Organizational; D044968:Regenerative Medicine / Q000191:economics / Q000458:organization & administration*; D012109:Research Support as Topic / Q000458:organization & administration; D057905:Stem Cell Research / Q000191:economics; D014481:United States