title: Logistics of stem cell isolation, preparation and delivery for heart repair: concerns of clinicians, manufacturers, investors and public health.
abstract: Recent developments in stem cell (SC) research challenge the long-held paradigm that the human heart cannot be repaired. While SC therapies for cardiac disease may not be available as soon as the public believes, it is important for investors, providers and clients to begin considering the expertise and facilities SC therapies may eventually require. Here we review several logistical issues that are integral to the development and delivery of SC therapy for cardiac disease. In the near future, quality control measures and sources of progenitor cells will be key determinants of treatment costs and clinical and research infrastructures. SC research and therapeutic development will yield greatest payoffs for patients and investors if insurance coverage can be obtained for therapeutic applications. This will require rigorous FDA review and approval for therapeutic use and Centers for Medicare and Medicaid Services coverage decisions.
authors.affiliation: Stanford University Medical Center, Cardiovascular Services, Stanford Hospital and Clinics, 300 Pasteur Drive, H3200, M/C 5230, Stanford, CA 94305, USA. TSalaway@Stanfordmed.org
authors.forename: Tarek
authors.initials: T
authors.lastname: Salaway
authors.forename: Dusko
authors.initials: D
authors.lastname: Ilic
mesh_terms: D001291:Attitude of Health Personnel; D006321:Heart / Q000503:physiopathology*; D006801:Humans; D011634:Public Health; D011786:Quality Control; D013048:Specimen Handling; D013234:Stem Cells / Q000166:cytology*; D014481:United States; D014486:United States Food and Drug Administration