To create a discrete room in the Life Sciences Building, over a dozen benefactors contributed more than $2.5 million to the University’s Center for Stem Cell Biology.

In theory, this privately funded room would allow researchers to develop new treatments and cures using human embryonic stem cells otherwise restricted by laws that restrict the use of federal funding for the research.

In practice, numerous practical, bureaucratic and legal obstacles have prevented University scientists from beginning their research.

“The room is fully equipped and ready to go,” said Sean Morrison, the center’s director.

But on the other side of the laboratory door- – protected by a lock programmed to deny access to anyone with a federally-funded salary – the room’s two incubators have yet to house a single stem cell.

Bureaucratic barriers

Since August of 2001, when President Bush restricted the use of federal funds to research stem cell lines derived before his address, researchers have struggled to obtain lines for research. Of the 60 lines registered with the National Institutes of Health, many were later found to be either incapable of growth or contaminated with animal proteins. Today only 16 are uncontaminated and viable for research and treatment.

Although these lines may be used to generate healthy tissue for patients who have lost cells because of disease, they are far from suitable for the type of research Morrison is interested in.

The creation of the room in the Life Sciences Building was supposed to solve that problem.

Now, though, before researchers can scour the world for suitable lines, they must complete several stages of approval at the University level.

In order for University researchers to obtain non-federally-approved lines, a Material Transfer Agreement must first be processed and documented by the University’s Division of Research Development and Administration, said Judy Nowack, the University’s associate vice president for research. The division assists researchers with external funding.

Tom Zdeba, who reviews the agreements, said they are used to monitor and track materials like stem cells and software individually.

But before a human embryonic stem cell transfer can be negotiated, the University’s Embryonic Stem Cell Research Oversight Committee must approve it.

Morrison said the committee was only established last week.

Zdeba, who works in the Division of Research, said this step allows members of the University community to monitor, track and make ethical decisions concerning stem cell technology.

Morrison said he supports this oversight and is a member of the committee himself – though he said he would recuse himself from approval process in issues concerning his own work.

He said he does not expect there to be any applications involving ethically problematic work.

Finding the lines

Even when researchers receive the necessary approval, the specific stem cell line needed for a project might not even exist.

The ability to derive new lines gives other schools in other states an advantage over the University, at which state laws prevent the creation of new lines, Morrison said.

“The law doesn’t protect embryos from destruction, it only prevents Michigan scientists from conducting medical research that is being done by scientists throughout most of the rest of the country,” Morrison said in an e-mail interview. “We’ve been leaders at the U of M in all research, and this legislation prevents us from doing many things with stem cells that we would like to do.”

For example, Morrison said he plans to use the privately funded lab to research heritable diseases like Huntington’s disease that result in the degradation of brain cells.

In most cases, if a parent carries the Huntington’s gene, the child will have a 50 percent chance of developing the disease. The high rate of heritability for Huntington’s disease, as well as its status as incurable and untreatable makes it attractive to researchers.

In order to study the disease, Morrison would need stem cells affected with Huntington’s disease, which are not included in the approved lines.

In this case, a good source for affected lines would be unused embryos from fertility clinics, Morrison said.

John Randolph, head of the Reproductive Endocrinology and Infertility Division at the University, said that although many couples seek the help of fertility clinics to achieve pregnancy, increased success of medical procedures such as in vitro fertilization has resulted in an abundance of embryos that will not be used.

“We have a lot of embryos in storage that have been here for a long time,” he said.

After three years, the embryos become property of the clinic and will likely never be implanted in a womb and carried to term.

“I wish we had a better solution for what to do with the embryos, but we don’t,” Randolph said.

Morrison said he would only need one stem cell line from an embryo affected by Huntington’s disease to begin his research.

“It is desperately needed research that could lead to breakthroughs that in the future might obviate the need for parents to discard these Huntington embryos,” Morrison wrote. “This is a fundamental principle of clinical trials in which we often perform experiments on patients that we know that we cannot save in order to learn new things that could help us to save future patients.”

Morrison said that by observing the stem cells affected with neurodegenerative diseases grow in a Petri dish he gain a better understanding of the diseases to apply toward different treatments that would slow or halt the destruction of brain cells caused by such diseases.

Morrison may not be able to start quite yet, but he is rehearsing for this research by practicing handling NIH-approved lines. He started experiments deriving neural stem cells and coaxing them to give rise to cells in the peripheral nervous system.

Morrison continues to prepare his privately funded lab in anticipation of newly derived embryonic stem cells that will help him in his pursuit.

Until then, the lab remains unused.

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