FDA-Approved Fetal Stem-Cell Treatment for Eye Disease Being Tested for Spinal Injuries
Company calls them ‘tissue-derived adult stem cells,’ but human fetuses are the source.
BY STEVE WEATHERBE
| Posted 5/29/12 at 12:58 AM
Stem cells derived from human fetuses will be injected into the eyes of a dozen patients suffering from age-related macular degeneration, under a clinical trial approved early this year by the U.S. Food and Drug Administration.
In mid-May, StemCells Inc. reported preliminary success in clinical safety trials with the same product on European patients with spinal injuries — the holy grail of potential stem-cell treatments. These trials are designed only to determine if the stem cells trigger tumors or immune reactions.
But the California-based, publicly traded firm isn’t touting the source of its designer stem cell, HuCNS-SC. On its website, it describes the product as “tissue-derived ‘adult’ (non-embryonic) stem cells.” And in its news release announcing the FDA’s approval, it is described as “purified human neural stem cells.”
However, LifeSite News, the Toronto-based pro-life news organization, dug into the firm’s website to find “human neural stem cells” described more brutally as “fresh human fetal brain tissue.” Further exploration of the company’s website reveals that the designation “‘adult’ (non-embryonic)” also turns out to mean “fetal.”
StemCells failed to respond to the Register’s request for comment.
Technical Window Dressing
Debi Vinnedge, president of Children of God for Life, a Florida organization devoted to fighting the use of fetal-derived products in both the food and drug industries, said it was a long-established practice in biological research to term all non-embryonic cells, whether from fetal, infant or adult stages, as “adult” because they share important characteristics that set them apart from embryonic cells. But she worries that StemCells Inc. may be using the term “adult” to disguise its lead product, thus insulating squeamish investors.
Not all fetal tissue is derived from morally problematic sources, Vinnedge said. “Parents could donate tissue from a miscarried child.” But since miscarriages often happen because of a problem with the unborn child’s health, researchers wanting healthy fetuses are more likely to end up with unborn children who were aborted, because they are generally viewed as healthy.
Fetal Tissue Strategy
Stem cells are undifferentiated, primitive cells that have the ability both to multiply and to differentiate into specific blood cells and other cell/tissue types. This ability allows them to replace dead or defective cells and/or tissues.
Embryonic stem-cell research, which involves the killing of a unique human being in an attempt to cure different diseases, has proven not only destructive and costly, but has not produced a cure. Adult stem-cell research, which utilizes cells from adult tissues or umbilical cords, does not require the destruction of human life. It has proven successful in treating more than 70 kinds of cancers and autoimmune diseases such as multiple sclerosis.
Pope John Paul II said that all research using stem cells from human embryos is “morally unacceptable.”
In his 1995 encyclical Evangelium Vitae, John Paul said, “This moral condemnation also regards procedures that exploit living human embryos and fetuses — sometimes ‘produced’ for this purpose by in vitro fertilization — either to be used as ‘biological material’ or as providers or organs or tissue for transplants in the treatment of certain diseases.
“The killing of innocent human creatures, even if carried out to help others, constitutes an absolutely unacceptable act.”
While embryos and fetuses are morally equivalent, the difference between them at the biological level is significant — especially for StemCells Inc.’s approach to developing cures. The embryo is a growing but amorphous mass of cells and the stem cells that direct its growth are “pluripotent”: Any stem cell can grow into or spawn any kind of cell. The embryo is renamed a fetus precisely when its stem cells specialize and distinct organs begin to form from them. StemCells Inc.’s approach is to rely on fetal stem cells because they have already developed to the point when they will only produce cells for certain organs. Therefore, they need less engineering before being injected into a diseased organ.
In the early days of stem-cell research, the focus was on embryonic stem cells because their pluripotency seemed to promise universal curative potential. Yet, even as celebrities and politicians trumpeted embryonic stem cells as cure-alls, researchers quietly admitted that they often triggered tumors in animal subjects.
StemCells’s patented HuCNS-SC cells are derived from the central nervous system of fetuses and designed to treat diseases affecting all parts of the system, including the eyes. So far, animal and human studies indicate that this approach could help provide an effective treatment. Reportedly, StemCells Inc. has resolved both the tumor problem as well as immune reactions to the injected tissue.
StemCells Inc. has just received FDA approval to test HuCNS-SC clinically on 16 human patients with an eye disease called age-related macular degeneration after successful tests on animals with a similar disease. While it did not cure the research subjects, it apparently did prevent further degeneration.
StemCells Inc. has also just confirmed a successful clinical trial on human subjects, using the same product to treat Pelizaeus-Merzbacher disease, which causes the myelin — or lining around nerve tissue — to degenerate. The four young patients treated with stem cells all showed new myelin production — an “unprecedented” development for those with the disease, according to StemCells Inc.’s news release.
Not everyone applauded the news. Dr. Theresa Deisher, president of Seattle-based AVM Biotechnology, said StemCells Inc.’s announcements regarding its tests on animals and clinical trials with human subjects were premature. In her view, the research using human beings in particular involved too few patients to be reliable. AVM Bio remains committed to adult stem-cell research, she said, for moral and technical reasons.
“We have products that are close to being ready to go,” she told the Register. AVM develops products that enhance the effectiveness of adult stem-cell treatments, which do not depend on the destruction of embryos or fetuses and do not present the technical obstacles embryonic stem cells do.
Meanwhile, therapies involving adult stem cells moved closer to implementation. In April alone, a UCLA research team announced the successful use of engineered adult stem cells to combat HIV/AIDS in mice, and Cleveland-based Athersys Inc. announced it had secured a patent on a product designed to reduce the immune reaction to adult stem-cell treatments for diseases such as leukemia.
Further, a Maryland firm, Osiris Therapeutics, has received Canadian approval to sell what it is billing as the world’s first stem-cell drug, Prochymal. Derived from adult stem cells, it will be used to treat children suffering from graft-versus-host disease. While other adult stem-cell treatments require implantation or injection, it will be administered as an ordinary prescription.
Register correspondent Steve Weatherbe writes from Victoria, British Columbia.
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