/images/logo.gif){kind=logo}
Market for adult stem cells multiplies |
| Date Added: March 16, 2008 08:27:05 PM |
| Author: Bruce Japsen-ChicagoTribune.com |
| Category: Research |
| A gathering known as the Stem Cell Summit might sound so controversial it would need a steely moderator, or even police protection, so politically delicate is the science of using embryos in medical research. But this affair at the Hilton New York on Sixth Avenue in Manhattan was all business because while the research community remains interested in embryonic stem cells, these days the focus is on the potential uses of adult stem cells, where it turns out that significant progress is being made away from the political spotlight. Picture, for example, a female breast cancer patient's own stem cells from fat tissue, processed and reinjected into areas where a lump was removed as a form of high-tech breast reconstruction. Or stem cells taken from bone marrow and placed directly in the heart via catheter to regenerate damaged areas that trigger heart failure. Stem cells are building blocks that theoretically can be manipulated to perform the work of many other cell types. The science is so new that stem cell products were virtually non-existent three years ago but are projected at $87 million in sales this year. Look ahead a decade, and the market could reach $8.5 billion, akin to the annual sales of the cholesterol drug Lipitor, the top selling prescription drug in the U.S. Progress in bringing adult stem cells to market outstrips the use of embryonic stem cells for several reasons, including that the regulatory hurdles are lower. But the controversy surrounding the process of harvesting cells from days-old embryos created in laboratories has clearly been a factor. While a small number of the companies appearing at the Stem Cell Summit are working on embryonic research, others go out of their way to point out they work only with adult stem cells. The Bush administration, citing the sensitivity surrounding the use of an embryo, has blocked certain federal funding of such stem cell research. But that potential hurdle could fall away soon because both leading Democratic presidential candidates and the likely Republican nominee support funding for embryonic research. The Food and Drug Administration already has developed regulations to deal with the coming rush of adult stem cell products from drug and device producers seeking approval later this year. "One of the pieces of rhetoric you hear all of the time is that the U.S. is far behind in stem cell research because of this or that but the fact is, we are not only the furthest along in the U.S., but the world," said Randal Mills, chief executive of Osiris Therapeutics Inc., who some call the Bill Gates of the stem cell industry. In January, Osiris won what is believed to be the largest stem cell contract in history, at more than $220 million, with the U.S. Defense Department's purchase of 20,000 doses of Prochymal for $10,000 each for a treatment to repair gastrointestinal damage caused by radiation. The Maryland company also has Prochymal in final-stage U.S. clinical trials for a condition known as "graft-versus-host disease," which affects some people with leukemia who reject bone marrow transplants. It is also being developed as a treatment for Crohn's disease. Stem cell products are being sold to treat rare blood disorders or to infuse spines, repair hips or reconstruct a patient's jaw for a dental implant. One is Osiris' Osteocel, a treatment derived from the bone marrow of cadavers that stimulates bone growth. Osteocel's sales jumped 83 percent to $15 million last year compared with 2006. "About 11,000 people have been treated in the U.S. with stem cell products in the last two years," Robin Young, a financial analyst who follows the stem cell industry, told more than 250 institutional investors and Wall Street firm representatives at the summit in New York last month. "Virtually all of the therapeutic stem cells that are or will soon be commercialized are adult stem cells," Young said. Companies with products on the market include StemCyte Inc., which is selling stem cells derived from donated umbilical cord blood that have been used in more than 600 patients in more than 30 countries to treat blood diseases such as rare forms of leukemia. StemCyte said its revenue -- which the privately held company declined to disclose -- is growing 50 to 70 percent annually. "We are practicing cellular therapy today and people wouldn't be alive if it were not for these therapies," said Kenneth Giacin, chief executive of StemCyte, which manages a cord blood cell bank and database for patients needing a transplant. Using sister's cells Gordon Chang said his daughter Chloe celebrated her 6th birthday in January thanks to the ability to preserve her younger sister's cord blood to combat a rare and deadly form of leukemia. At age 1 1/2, Chloe embarked on 18 months of failed treatments that started with chemotherapy followed by a dangerous arsenic treatment and a transplant of stem cells from her own blood before she was treated with an infusion of 2 to 4 ounces of her sister's stem cells preserved by StemCyte. Although each of her earlier treatments involved a month to several months of remission, they were not as effective as cord blood, said Gordon Chang, a Stanford University history professor. Side effects involved severe pain and bleeding, but Chang said his daughter today is healthy and in 1st grade, three years after the infusion with cells from cord blood. "There are no guarantees about the future," he said. "But this would have been impossible without the umbilical cord [stem cell] transplant." StemCyte, based in Covina, Calif., a Los Angeles suburb, is embarking on clinical studies to examine other applications for cord blood stem cells, including cancer treatment and heart regeneration. "We have this gold in our inventory but we want to plant seeds for the future," Giacin said. Baxter cell separator The stem cells used by StemCyte and Osiris' Osteocel do not require clinical trials and FDA approval for marketing because they are essentially cells that are harvested, processed and stored for a later use, much like organs used for transplant, and not manipulated. That makes it easier for companies to commercialize them. Stem cell therapies will face their stiffest challenge when Osiris submits Prochymal to the FDA, perhaps by year-end, because the product involves manipulation of cells and has therefore had to go through several years of clinical trials in humans. Stem cell products, some of which are just entering final stages of clinical trials, are derived from building block cells that are able to develop into many different types of specialized cells, serving as a sort of repair system for the body. Theoretically, they divide without limit to replenish other cells as long as the person or animal is alive. One stem cell product is undergoing a 150-patient clinical trial funded by Deerfield-based medical products giant Baxter International Inc. that uses Baxter's Isolex cell separation and collection system to extract stem cells from the many types of cells in bone marrow. The cells, once carefully isolated using the machine, are injected into the heart via catheter in hopes of regenerating damaged areas that trigger heart failure. The trial could be completed by early next year. A similar effort that uses a machine to harvest stem cells from fat tissue for use in breast reconstructive surgery is being pursued by San Diego-based Cytori Therapeutics Inc. The device is already approved in Europe and the company eventually plans to do clinical trials in the U.S. to win approval here. Cytori's Celution System takes a patient's own adult stem cells from fat tissue, separates the cells, processes them and returns them to the patient via injection. The company this year introduced the system to the European plastic and reconstructive surgery market and plans to eventually do U.S. clinical trials. "We would like our first indication to be breast reconstruction," said Dr. Eric Daniels, Cytori's senior director of business development. It is unclear when the Baxter and Cytori devices will reach the FDA approval stage, but companies are watching closely to see Prochymal's prospects for approval. "We believe we have the regulations in place to address these types of stem cell products and for the products coming down the road," said Mary Long, a spokeswoman for the FDA. "These regulations provide us with a flexible approach. We think it is a good starting point." |
Ratings:
You must be logged in to leave a rating.Average rating: ( votes) |