New Source of Therapeutic Cells May Reduce Cancer Costs, Recurrence
The first device to successfully grow functional, therapeutic human cells outside the body may reduce the costs, complications, and pain associated with cell-transplant therapies for patients with cancer and other diseases, early studies suggest. The cell-culturing bioreactor was designed by Aastrom Biosciences, Inc., of Ann Arbor, Mich., with co-funding from NIST's Advanced Technology Program (ATP). The desktop-sized device induces the growth of stem cells, which normally reside in the bone marrow of healthy individuals and mature into blood and immune system cells. The new technology could offer a less invasive alternative to the current practice of harvesting large amounts of stem cells from the bone marrow or blood of donors (often the patients themselves) for transplant into patients whose own stem cells are absent or damaged. For example, traditional methods require up to 140 painful skin punctures to harvest 1,000 milliliters (ml) of bone marrow, whereas Aastrom's approach requires only one puncture to withdraw approximately 40 ml, which then is expanded to the desired larger volume in the bioreactor. The ATP funding accelerated by up to two years the design and construction of the experimental cell-culturing chamber and instrumentation for automated operations. The project also provided the basis for more than 100 scientific papers and 14 patents owned or licensed exclusively by Aastrom and helped the company attract more than $70 million in private investments. The technology has passed initial safety and efficacy tests, and the results of preclinical studies are promising. For example, two studies showed that cells grown outside the body were less contaminated with tumor cells than the patients' own bone marrow, suggesting that cancer may be less likely to recur using the new approach. Clinical studies are now under way with more than 70 patients at six sites in the United States and Europe. If these studies are successful, then the technology is likely to be approved by the Food and Drug Administration for clinical use. The technology could offer many additional benefits, such as expanded therapeutic use of stem cells from umbilical cord blood (which is easy to collect and may overcome the problem of tissue incompatibility between donor and recipient) and new gene therapies, such as methods for conferring resistance to AIDS. ATP funding: $1,220,000 June 1998
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