International Stem Cell reports that its new production facility for clinical-grade stem cell products has passed final building inspection. Located in Oceanside, CA, it consists of separate suites for development and production of different cell types from the company’s human parthenogenic stem cell (hpSC) technology.
The facility is located in close proximity to the fertility clinics that provide donated human eggs under ISCO’s recently established partnerships. It is also near the research institutions with whom ISCO collaborates on fundamental stem cell biology and therapeutic applications.
ISCO says that it aims to demonstrate the therapeutic applicability and the potential immune-rejection advantages of hpSC lines relative to other stem cell classes. Human embryonic stem cells (hESCs) derived through parthenogenesis are currently not allowed to obtain NIH funding under the institute’s guidelines.
After President Obama signed the executive order to lift former President Bush’s ban on NIH funding for hESC research, the NIH put together a set of rules for informed consent and evaluation of eligible hESC lines in July 2009. Subsequently 43 lines have been incorporated into NIH’s registry.
While researchers across the board are ecstatic with this new outlook on hESC-based research, many have voiced concerns over the decision to prevent funding for cell lines created through parthogenesis as well as another technique called somatic cell nuclear transfer, citing its many advantages. The NIH states that the guidelines reflect the fact that there is no clear consensus among the public yet about how ethical the process is.
Like hESCs, hpSCs are pluripotent yet avoid ethical issues associated with destruction or use of viable human embryos, ISCO emphasizes. Unlike iPSCs, hpSCs do not require manipulation of gene expression back to a less differentiated stage, which may prove to be a safety or regulatory obstacle. And, unlike both ESCs and iPSCs, hpSCs can be created in a homozygous form such that each line can be an immunological match for millions of patients.