Table 2 Challenges for induced pluripotent stem cell use in regenerative medicine

Consent

Model consent and donor testing, including possible sourcing from existing tissue banks [9]

Method of induced pluripotent stem cell generation

Integration-free methods: plasmid and Sendai virus versus two-step integration and excision methods – that is, STEMCCA (EMD Millipore Corporation, Billerica, MA, USA) – and newer methods being developed [10]

Patents and licenses

Freedom to operate versus reach-through claims by companies to enable translation but also provide financial commercial incentive [8, 11]

Characterization and testing

Pluripotency, differentiation ability, mycoplasma and viral testing, HLA typing and identity, and large-scale analysis need to be done in a standardized, efficient, and cost-effective manner. Not all tests are currently available [12].

Distribution

American Type Culture Collection (Manassas, VA, USA), Coriell Institute (Camden, NJ, USA), Rutgers University (New Brunswick, NJ, USA), WiCell (Madison, WI, USA), PACT (Production Assistance for Cellular Therapies) Program, and other biobanking institutions need a financially sustainable model [13].