The future may not exactly rest in the figurative hands of stem cells, but David Magnus, Ph.D., director at Stanford Center of Biomedical Ethics and professor of medicine and biomedical ethics, pediatrics at Stanford University, acknowledges that the stakes are high. “There are tremendous expectations of stem cell research and what it can mean for personalized medicine,” he says.
“The public and many patients want treatment, and they want it today. The downside of the hype is that clinical trials take time, and people want answers now,” Dr. Magnus adds.
“If only we had a working crystal ball and could see what’s coming—which trials are going to succeed. But this is the challenge,” says Robert J. Deans, svp, regenerative medicine, Athersys. “This is a high-profile area of research. When things succeed, they raise hopes among researchers, the public, and, of course, among investors. When they fall short, they also dramatically impact expectations across the board. The benefits can be incredible, but so are the risks, particularly when you get to the pivotal clinical trials stage.”
These themes will loom large at CHI’s upcoming CHI “Molecular Medicine” conference. The meeting will focus heavily on the practical and regulatory ramifications of moving stem cell research through the clinic and drill down into some of the research currently moving through the clinic.
Basic research in stem cells is moving forward quickly, Dr. Magnus notes. “There is a lot happening in the field with regard to differentiated cells—for example, the phrase ‘stem cells’ is often applied to bone marrow transplantation or transplantation of primary cells derived from bone marrow,” he says.
“I will be concentrating on the use of far less-established applications including use of human embryonic stem cell (hESC)-derived stem cells. The real challenges in this field are at the frontier—not standard, well-established areas of research.”
One big challenge to the future of stem cell research, says Dr. Magnus, is an obvious one—specifically, to find the funding to do the research. “State funding and CIRM money is going to be ending in a few years. The amount of federal funding is not growing, and there are legal and political challenges to what can be funded. Largely, states will be responsible for funding, and having that funding slow down also presents a challenge,” he reports.
“The legal challenge is how will NIH fill the funding gaps, as there is a huge monetary limitation in the field. Also, you look at the political landscape and wonder how a promising young scientist is going to find his or her way, as there are limits to the cell lines you can use. Researchers can’t always get funding because of the political landscape. And as we move forward with clinical trials, we are nervous about how high-profile clinical trials are going to go.”
Of major concern, says Dr. Magnus, are the incredibly high public expectations. “Public expectation is unrealistic, and when you throw in a high-profile death, we don’t want what happened to gene therapy to happen to stem cells,” he cautions. “Jesse Gelsinger’s death caused the gene therapy field to take a major hit, from which it still hasn’t recovered. Stem cell research would do well to avoid such a tragedy. At the frontiers, the risks and the rewards are the biggest.”