Steps to the Clinic

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Steps to the Clinic
Beverly A. Purnell and Pamela J. Hines

"Researchers announce major step in stem cell research!" This now familiar claim extols the virtues of fresh research propelling us yet another step toward the clinic. We greet the news with excitement and then follow with "So how much farther?" Well, it's hard to say. The stairwell leading to the clinic seems to display twists, turns, and bifurcations and often lacks handrails. In addition, many of the building materials (progenitor cells or differentiated cell types), technologies (such as delivery method), and destinations (optimal regenerative tissues) are undefined as yet. To make the climb even more challenging, not all steps are created equal, with some treads and landings missing structural elements, leading to the occasional stumble.
But basic researchers serve as able guides for the climb. Their research on model organisms provides a firm grounding in stem cell biology. Such research is exemplified in a Review by Stappenbeck and Miyoshi (p. 1666), which describes stromal stem cells as they function in wound repair, and in a Review by Johnston (p. 1679), which tells of cell competition in somatic and germline cells of Drosophila. In addition, collaborative interdisciplinary efforts enable us to reach greater heights at an expedited pace. As Discher et al. (p. 1673) outline, new technologies can be used to parse complicated in vivo mechanisms to elucidate biophysical properties of stem cells and their microenvironment.
Cellular events occasionally go awry, as in cancer. There is much current interest in the biological properties of cancer cells with relevance to stem cell biology. Rosen and Jordan (p. 1670) tell how research on cancer stem cells, despite being an area of considerable controversy, is revealing potential targets for cancer therapy.
Safeguards for stem cell research are supported by regulatory bodies such as the U.S. Food and Drug Administration (FDA). In a Perspective, Fink (p. 1662) explains the role of the FDA in evaluating the safety of stem cell-based products intended for clinical application. Additional guidelines are even now being established by the National Institutes of Health [see the related Editorial by Pedersen (p. 1617) and Policy Forum by Majumder and Cohen (p. 1648)]. Guidelines and regulations are critically necessary, but, all too frequently, patients and their families feel that not enough progress is being made. The associated heartfelt urgency may lead to poor medical decisions taken by those who want to scale flights quickly when there is limited time. In a Perspective, Lindvall and Hyun (p. 1664) distinguish between responsibly extending the stairway into uncharted territory—the course of medical innovation—and taking leaps into the unknown that are driven more by hope than thought.
Although the steps to the clinic are still under construction, we are seeing exciting progress. The ascent is made easier through interdisciplinary research and improved communication among researchers, clinicians, and bioengineers. All the while, consultation with policy-makers and ethicists is crucial. Now we press onward, taking care to test our steps and build as we go.
-------From Science June 2009

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