U plans trials in humans

by Geoffrey Ziezulewicz

The University’s Academic Health Center will begin human clinical trials with stem cells late this year that will continue into early next year, University officials said Monday during a stem cell presentation at the State Capitol.

Pending approval from the Food and Drug Administration, trials attempting to put stem cells to therapeutic use in humans would begin late this year for adult stem cells and early next year for embryonic stem cells, said John Wagner, clinical research director at the University’s Stem Cell Institute.

The University will be the first public research institution to conduct human clinical trials with stem cells, said James Battey, chairman of the Stem Cell Task Force for the National Institutes of Health.

“This is the cutting edge of implementation,” Battey said of the University’s initiative.

Wagner said the University is in the process of briefing the FDA, the National Institutes of Health and the United Nations on the human clinical trials.

“This is a tremendous undertaking for a tremendous gain,” Wagner said.

Neither Wagner nor other University officials present would comment further on the upcoming trials.

The announcement came during a presentation to the Minnesota House of Representatives Higher Education Finance Committee.

The overview, given by Wagner and Academic Health Center Vice President Frank Cerra, attempted to fill legislators in on what the University has done with adult stem cells and what it hopes to do with embryonic stem cells.

The University has long been a leader in cellular biology research and applications, Cerra said.

Some of the basic science needed for stem cell work originated at the University, he said, and the University has invested in technology and faculty to further this research area.

“The possibilities are only limited by our imagination and the scientific work we are able to perform,” Cerra said.

While the University has “actively recruited” prominent stem cell researchers in the past few years, Cerra said there is a search under way to recruit a brain stem cell researcher.

The University’s status as a public institution means that any embryonic stem cell research will be transparent and accountable, Cerra said.

Researchers decided to pursue stem cell research, he said, and not allowing it could mean an exodus of talent from the institution and the state.

“If Minnesota scientists don’t perform this cutting edge research, someone else will,” he said.

While research has already been done at the University regarding adult stem cells, Wagner said embryonic stem cells, combined with knowledge of the human genome, could offer a “pre-emptive strike” against many diseases.

Taken from an unused human embryo, embryonic stem cells could be used to repair damaged tissue from a heart attack or cancer, he said.

During his presentation, Wagner showed film of embryonic stem cells that had been nurtured into becoming beating heart cells.

“This can only be done with embryonic stem cells,” he said. “They remain the gold standard.”

He said embryonic stem cells have more promise because they are more versatile and easier to work with than adult stem cells.

“These cells like to go to the area of damage,” Wagner said of stem cells.

Wagner said the lines currently available through the U.S. government are too few and too old to be viable sources.

“These are old, heavily cultured lines,” he said. Such cells tend to pick up defects the longer they are cultured and “even if we created 100 more today, they’d have a limited shelf life.”

Wagner said new stem cell lines will also be needed for human trials because the old ones used a layer of mouse cells to help the stem cells grow.

Legislation is making its way through the Minnesota Senate and House for and against embryonic stem cell research.

Rep. Gene Pelowski, DFL-Winona, attended the briefing and said he was curious about the possibility of the University patenting and licensing some of the developments from the research.

Cerra said it is too early to know, but the University has good systems in place to help it recover royalties should the research create any licensable intellectual property.

“I hope we find the resources to help you,” Pelowski said.