Patients with severe spinal-cord injuries will be the first humans to be included in an embryonic-stem cell experiment. The Food and Drug Administration approved the clinical trial this week, marking the first time embryonic stem cells will be used in human testing.

Adult stem cells have already been used in cancer, bone marrow and spinal-cord injury treatments for humans, but so far only animals have been used in embryonic stem cell research.

The tests will be to measure primarily the safety of the procedure. The performance of the therapy - whether it actually works - is a secondary concern of Geron Corp., the medical group responsible for administering the trial. Scientists will track the patients to see whether their conditions improve.

"The FDA's clearance of our GRNOPC1 IND is one of Geron's most significant accomplishments to date," said Geron president Thomas Okarma, Ph.D., M.D., in a statement released to the press. "This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells.”

Masaaki Tamura, associate professor of anatomy and physiology at Kansas State University and stem-cell researcher, said he was not concerned there would be any problems with the FDA-approved experiment and said that, despite this progress in embryonic stem-cell research, he thought other forms of stem-cell research still had more potential.

“I think it’s a good thing, and I don’t think there is anything to worry about,” Tamura told Kansas Liberty. “But it probably doesn’t change much, as embryonic is a very powerful and primitive stem cell and they are difficult to handle. There are also the ethical issues with them, so I don’t see this having so much of a strong impact.”

Tamura said he thought the future of productive stem-cell research would be discovered within adult stem cells, as well as iPs cells, which are human cells, generally taken from a person’s skin, that are manipulated to act like an embryonic stem cell.

“The technology-induced embryonic stem cells are already available and people are moving more towards that,” he said.

Tamura does not use embryonic stem cells in his research and has been focusing on utilizing adult stem cells harvested from an area in the umbilical cord called Wharton’s jelly for his research. 

The new FDA approval has surfaced in the wake of the inauguration of President Barack Obama, an embryonic stem cell research supporter. Obama has vowed to lift former President George W. Bush’s ban on the usage of federal funding for the controversial embryonic stem-cell research.

Opponents of embryonic-stem cell research are concerned that federal dollars may be funneled away from adult stem-cell research, which has already been proven effective in human treatments. However, proponents are praising Obama’s intentions, saying his support may be the boost embryonic stem-cell research needs to finally be used as successful treatment in humans.

Rep. Peggy Mast, R- Emporia, said she was unsure how lifting the funding ban would impact Kansas.

“I don’t know at this point whether or not the federal government taking action on this is going to supersede anything taking place at the state level,” Mast told Kansas Liberty. “I think Obama lifting the ban is egregious, and I think it will just lead to experimentation that will take us down a road that we just do not want.”

The difference between the two types of stem cells, and the cause of the controversy, is the location from which they are harvested. Adult stem cells can be harvested from the patient’s own body, an umbilical cord or amniotic fluid, and embryonic stem cells are harvested from an embryo. The harvesting of the embryonic stem cell destroys the embryo, which opponents argue destroys a human life.

Although the FDA’s decision may excite embryonic stem cell research supporters, earlier this month new research by Mickie Bhatia, professor in biochemistry and biomedical sciences at McMaster University, located in Canada, further demonstrated the ongoing problem with embryonic stem cells, which is their tendency to cause tumors.

Bhatia found that the embryonic stem cells researchers are generally more likely to use for research, because they appear to be the healthiest, are also the embryonic stem cells that are more predisposed to causing tumors or abnormal cells.

“Current measurements are not capable of distinguishing the difference between great stem cells and cancer stem cells in vitro," Bhatia said in a Nature magazine article.

Dr. David Prentice, senior fellow for life sciences at the Family Research Council and stem-cell research expert, said that though there is generally no protocol of how to select embryonic stem cells, researchers tend to be drawn to the cells that are able to grow quickly- and according to Bhatia’s research, these are the cells that are more likely to cause tumors.

“It would then be a reasonable assumption that you should opt for more stable and slower growing cells, but it's hard to say whether some abnormalities won't crop up over time, and you would still have to watch that slow-growing cell carefully to make sure it didn’t take on the fast-growing characteristic,” Prentice told Kansas Liberty. 

Prentice said that despite the fact that embryonic stem cells are generally unstable, many researchers find them attractive because they are capable of making all or most of the tissues in the body.

“Researchers are fascinated by the flexibility of the cells, but it’s that flexibility of the cells and that growth capacity that makes them very difficult to control,” he said.

Prentice said these new findings are just one more reason to demonstrate why funding and research should be dedicated to adult stem cells.

Kenneth Peterson, professor and vice-chair of the Department of Biochemistry and Molecular Biology at the University of Kansas Medical Center, said that researchers at the university are pursuing embryonic stem-cell research in their work.

“One of the cornerstones of the University of Kansas Medical Center's mission is the discovery of new knowledge in the quest for life-saving cures and preventive interventions,” Peterson told Kansas Liberty.

“In order to fulfill our mission and serve those who depend on us for new therapies and cures, we have an obligation to explore research that holds much promise for profoundly easing human suffering," he said.  "This obligation includes the pursuit of all research available under current law, as well as under current ethical and regulatory guidelines.”

A Family Research Council press release on the FDA’s approval cautions that a significant number of studies in animals using embryonic stem cell have shown the tendency of the stem cells to form tumors, and that the patients used in this clinical trial will need to be monitored for potential tumors for the rest of their lives.

- Holly Smith

Resources:

• An Associated Press report

• The Geron statement

• Nature magazine article

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