title: Developing Induced Pluripotent Stem Cell-Based Therapy for the Masses.
abstract: The discovery of induced pluripotent stem cells and the ability to manufacture them using clinically compliant protocols has the potential to revolutionize the field of regenerative medicine. However, realizing this potential requires the development of processes that are reliable, reproducible, and cost-effective and that at the same time do not compromise the safety of the individuals receiving this therapy. In the present report, we discuss how cost reductions can be obtained using our experience with obtaining approval of biologic agents, autologous therapy, and the recent approval of cord blood banks. Significance: For therapy to be widely available, the cost of manufacturing stem cells must be reduced. The steps proposed in the present report, when implemented, have the potential to reduce these costs significantly.
authors.affiliation: Q Therapeutics, Salt Lake City, Utah, USA Wake Forest Institute for Regenerative Medicine, Wake Forest University, Winston-Salem, North Carolina, USA mrao@qthera.com.
authors.forename: Mahendra S
authors.initials: MS
authors.lastname: Rao
authors.affiliation: Wake Forest Institute for Regenerative Medicine, Wake Forest University, Winston-Salem, North Carolina, USA.
authors.forename: Anthony
authors.initials: A
authors.lastname: Atala
mesh_terms: D001771:Blood Banks / Q000191:economics / Q000331:legislation & jurisprudence; D003362:Cost-Benefit Analysis; D005312:Fetal Blood / Q000637:transplantation; D006801:Humans; D057026:Induced Pluripotent Stem Cells / Q000637:transplantation*; D011358:Product Surveillance, Postmarketing; D044968:Regenerative Medicine / Q000191:economics* / Q000331:legislation & jurisprudence / Q000379:methods; D033581:Stem Cell Transplantation; D014481:United States; D014486:United States Food and Drug Administration