NIH reapproves WiCell’s H9 and three other Wisconsin stem cell lines for federally funded research

Today the National Institutes of Health reapproved the WiCell Research Institute‘s H9 (WA09) human embryonic stem (ES) cell line, the most used and cited in scientific research, for ongoing use in federally funded research.

It also reapproved three of the other original “Wisconsin” lines, H7 (WA07), H13 (WA13) and H14 (WA14). These four Bush-era lines along with WiCell’s H1 (WA01), which was reapproved by the NIH in January, date to the 1998 discovery of these unique and revolutionary cells in the University of Wisconsin–Madison lab of Dr. James Thomson. They have been used in hundreds of federal research projects, as allowed under the Bush administration, since 2001.

Last July, when the NIH adopted its new approval guidelines for human ES cell lines, the Wisconsin lines and the 15 other previously approved lines under the Bush administration, were not grandfathered for federal funding eligibility. Instead, the same detailed application and documentation required for new lines were required for Bush-era lines.

The application process for H7, 9, 13 and 14 took longer than the H1 line, derived from an embryo donated through a Wisconsin IVF clinic, because the embryos for these lines were provided by a collaborator of Thomson, Dr. Joseph Itskovitz-Eldor, and donated through a medical center in Israel. Itskovitz-Eldor is a professor of medicine and a distinguished stem cell researcher at the Technion-Israel Institute for Technology in Haifa.

“With these embryos originating in Israel more than a decade ago, it took significant time and effort to locate, gather and translate the documents from Hebrew to English, so we could complete the application,” stated Erik Forsberg, executive director of WiCell, a private nonprofit affiliated with UW–Madison. “Without Dr. Itskovitz’s collaboration, persistence and contributions to stem cell science, we never could have completed the applications, nor would the derivation of these lines have occurred.”

Forsberg stated, “It was important to Dr. Itskovitz that the NIH reapprove these lines so WiCell can continue supplying them to scientists for use in federal research projects. Many researchers have invested years studying these specific cell lines, so without this approval, millions of dollars of time-consuming research could have been set back for years, or even ended.”

The five Wisconsin lines accounted for greater than 80 percent of the orders placed through the former National Stem Cell Bank, operated by WiCell until February when NIH ceased funding of a national bank for stem cell distribution. In early February, WiCell, which has distributed stem cells worldwide since 1999, transitioned all 20 of the Bush-era lines previously available through the NSCB to its own WISC (Wisconsin International Stem Cell) Bank to ensure researchers a continued supply.

Often called the “gold standard” by stem cell researchers due to its stability and longstanding use, H9 accounted for 40 percent of all NSCB orders, and is cited in more than 550 scientific publications; H1 attracted 29 percent of orders; and H7 9 percent.

In addition to banking the Bush-era lines, modified versions of the Wisconsin lines, and induced pluripotent stem cell lines (created by genetically reprogramming adult cells without the need for an embryo), WiCell is eager to expand its WISC Bank by adding cells from a wide variety of providers.

WiCell also has developed other new products and services, including a clinical-grade H9 human ES cell line meeting stringent cGMP quality control standards. Developed in partnership with the Waisman Clinical Biomanufacturing Facility, WiCell now offers researchers matched cGMP and research cell banks that allow them to transition smoothly from early research phases through clinical application. WiCell and the WCBF plan to offer a wide variety of other cGMP lines, including lines produced from newly derived, fully compliant human ES cells and induced pluripotent stem cells.

Other new offerings include the availability of WiCell’s expert cytogenetics lab for use by academic and commercial labs to monitor chromosome stability in stem cells. With highly specialized equipment and experienced research and technical staff, WiCell’s cytogenetics lab performs karyotyping, array comparative genomic hybridization and other specialized tests with quick turnaround times.