The creation of therapies using stem cells is still in early stages, with only two such products approved in North America.
HEMACORD, a cell therapy derived from hematopoietic stem cells, was approved by FDA in November 2011, and Prochymal, a stem-cell
treatment for treatment of host versus graft disease in children, was approved by Health Canada in May 2012. The pipeline,
however, is robust: According to a 2013 report from the Pharmaceutical Research and Manufacturers of America (PhRMA), there
are 69 cell-therapy products in clinical development in the US, indicating a high level of interest in this class of therapeutics
Photo courtesy of the Bhatia Laboratory, McMaster Stem Cell and Cancer Research Institute (SCC-RI)
THE ONTARIO STEM-CELL CLUSTER
The development of stem-cell therapeutics is fueled by an active research effort, with a particularly dense concentration
of resources in Ontario, Canada. According to the Ontario Ministry of Research and Innovation, Ontario boasts one of the largest
population of stem-cell researchers in North America. The Ontario Stem Cell Initiative (OSCI) is a network of more than 85
stem-cell and regenerative medicine research programs in Ontario, representing scientists from McMaster University, Ottawa
Hospital Research Institute, University of Toronto, and University of Western Ontario. The Cancer Stem Cell Consortium, which
leverages international collaborations, the Stem Cell Network, and the McEwen Centre for Regenerative Medicine also function
to promote collaboration among the area's stem-cell researchers. According to Jason Field, executive director of Life Sciences
Ontario, "What really sets us [Ontario-area researchers] apart is our openness to collaborations. Ontario leads many provincial,
national and international research collaborations that have furthered our scientific understanding in several research areas,
not the least of which is stem cells and regenerative medicine."
The research effort is carried out with an eye toward commercialization. Says Field, "Ontario recognizes the need to turn
our world-class research into commercialized technologies and companies that can generate jobs and other socioeconomic benefits.
To that end, the province has created the ONE (Ontario Network of Excellence) —a collaborative network of organizations across
the province dedicated to assisting innovators, researchers and entrepreneurs commercialize ideas. Included in the ONE are
leading accelerators like MaRS Innovation and the Ontario Centres of Excellence."
Toronto is home to the Centre for Commercialization of Regenerative Medicine (CCRM), a not-for-profit organization that focuses
on the development of technologies that can accelerate the commercialization of stem cell- and biomaterials-based products
and therapies. "We're very focused on cell manufacturing as one of our major pillars. CCRM is an interesting model to consider,
because it tries to bring industry and academia together to solve fundamental problems, ones not necessarily centered around
someone's IP but more on problems that are holding back industry," says Peter Zandstra, chief scientific officer at CCRM.
Following is a discussion with Ontario life-sciences researchers about the utility of different classes of stem cells for
regenerative medicine, as well as discussion of delivery strategies, manufacturing considerations, amd the obstacles in commercialization
when developing stem cells as therapeutics.