Unleashing the Promise

An up-close look at some companies that may soon bring stem cell-based therapies to market.
Apr 01, 2005

Two Months Before Former President Reagan died, Nancy Reagan delivered a grim yet hopeful message to an audience at a Juvenile Diabetes fundraiser. Referring to her husband's long battle with Alzheimer's disease, Mrs. Reagan said, "Ronnie's long journey has taken him to a distant place where I can no longer reach him. I'm determined to do what I can to save other families from this pain, and now science has presented us with a hope called stem cell research." Her remarks garnered a great deal of attention and, when the former president died, the public fervor around the debate escalated.

David Beck, PhD, President, Coriell Institute
Continued Controversy The heat in this discussion was first ignited in 2001, when President Bush limited federally funded embryonic stem cell research to stem cell lines that were already in existence. At that time, 78 cell lines met the requirements, yet only 19 of those lines were available for study. Since then, demand for access to embryonic stem cell lines has swelled, prompting universities such as Harvard, Stanford, Massachusetts Institute of Technology, and the Universities of Wisconsin and Minnesota to use private money to pursue research initiatives.

Also in 2001, David Beck, PhD, president of the Camden, New Jersey–based Coriell Institute for Medical Research, which houses the largest repository of cell cultures in the world, made a prescient remark: "Much of the controversy regarding embryonic stem-cell research will go away, because we're learning so much about stem cell biology." Beck stands by his prediction. "There will always be some controversy of course," he says now. "However, in time the arguments framed by Nancy Reagan will prevail." Ella de Trizio, a partner in Princeton, New Jersey–based Dechert, which provides venture capital financing for life sciences companies, shares Beck's enthusiasm. "It's important to remember that in addition to getting past the political stigma, developing stem cell-based therapies is really no different than any other biotech endeavor. You have to take the long view," she says.

Although Beck says there has been noteworthy progress in embryonic research, he cautions that there are challenges. "With all stem cells, there are issues that we need to understand better in order to harvest their potential," he says. He also notes that embryonic stem cells are harder to work with than previously believed because "they tend to form structures that are not completely within our control."

New research published in Nature Medicine on January 23 highlights yet another challenge: The cell lines currently approved for study under federal funding contain a non-human molecule, the sialic acid Neu5Gc, which elicits an immune response in humans. "The problem is that these human embryonic stem cell lines have been grown in such a way that they are contaminated by animal protein and cannot be used for human therapeutic purposes," Beck explains.

Meanwhile, adult stem cell research is pushing the science ahead at a steady clip. Beck cites cancer research as a relevant analogy: "In the nineteen seventies Richard Nixon declared war on cancer. Everyone expected an instant cure, but it wasn't like that. Though we haven't cured cancer, we've learned a lot about basic biology, cells, and genes. We've made substantial inroads against cancer. And these applications are coming to market in a deliberate and precise way." Beck predicts that stem cell-based therapies will also come to market in a systematic fashion.

R. Douglas Armstrong, PhD, chairman and CEO, Aastrom Biosciences
In April 2004, 204 members of the House of Representatives, including 36 Republicans, signed a letter urging President Bush to rethink the restrictions on embryonic stem cell research, suggesting that hundreds of thousands of embryos stored in in-vitro fertilization (IVF) clinics could be used to advance embryonic stem cell research.

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