The shift in stem-cell policy by the Obama administration and ensuing federal guidelines for human stem-cell research is creating renewed interest in the potential of regenerative medicine as a therapeutic option. As a case in point, the advocacy group, the Alliance for Regenerative Medicine, was formed earlier this month to promote regulatory, research, and reimbursement policies that will foster innovation in regenerative medicine. The alliance, which includes universities, life-science companies, and healthcare investors, will also serve as a source of information about regenerative medicine for policymakers, the media, and the general public. As the bioethics of certain types of regenerative medicines are debated and its scientific potential evaluated, a bottom-line question arises. Can regenerative medicine generate sufficient financial returns to make it a viable option for the pharmaceutical industry?

Regenerative medicine is defined as the process of creating living, functional tissues to repair or replace tissue or organ function lost due to disease, damage, congenital defects or age, according to the National Institutes of Health. This process may include: regenerating damaged tissues by stimulating previously irreparable organs to heal themselves; using stem cells to grow cells, tissues, and organs to repair damaged or destroyed cells and tissue the body cannot heal by itself; and helping to address the problem of the shortage of organs available for donation compared with the number of patients that require organ transplantation, according to an Alliance for Regenerative Medicine press release.

Initial charter members of the alliance include: universities and research institutes Wake Forest Institute for Regenerative Medicine, Stanford University, the University of Washington, Georgia Tech University, and the Genetics Policy Institute; life-science companies Geron, Johnson & Johnson, Aldagen, iZumi, Fate Therapeutics, and Maxcyte; and investor organizations: Kleiner, Perkins, Caufield and Byers, and Proteus Ventures. Alliance organizers will announce the final list of charter members later this month.

Currently, there is no firm answer as to the financial viability of regenerative medicine as a therapeutic option, but as the founding members of the alliance show, it is an approach that merits further consideration. This view is shared by others as evidenced by some recent activity in this field.

For example, in November 2008, Pfizer formed a new, dedicated research unit, Pfizer Regenerative Medicine, which will explore the use of stem cells to develop future treatments with the goal of delivering new medicinal products using cells as therapeutics, according to a Pfizer press release. The research unit, based in Cambridge, England, and Cambridge, Massachusetts, is expected to employ around 70 researchers.

Earlier this month, a new start-up company, iPierian, was formed from the merger of two biotechnology companies, Pierian and iZumi. Ipierian’s specific focus is on the industrialization of induced pluripotent stem-cell technology with the goal of creating new therapeutics through cellular reprogramming and directed differentiation of patient cells. The company secured an additional $11.5 million in venture-capital funding this month to augment seed financing of $20 million. Corey Goodman, former head of Pfizer’s Biotherapeutics and Bionnovation Center, is chair of the new company, and iZumi CEO John Walker will lead iPierian.

Admittedly, these efforts in regenerative medicine, along with others, are but a drop in the sea of the multibillion-dollar expenditures in pharmaceutical research and development. But it is these efforts that will ultimately have to be the judge and jury of the scientific and economic feasibility of regenerative medicine.