University Plans Human Stem Cell Trials

By Associated Press

March 23, 2004.

ST. PAUL -- The University of Minnesota is awaiting approval by the U.S. Food and Drug Administration to begin several months of clinical trials into the therapeutic use of stem cells in humans.

The university would 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.

In one set of trials, researchers will use stem cells taken from adults. Another set of trials will use stem cells harvested from embryos, state lawmakers were told Monday by John Wagner, clinical research director at the university's Stem Cell Institute.

Wagner said the university is in the process of briefing the FDA, the NIH 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 House Higher Education Finance Committee. The summary, presented by Wagner and Frank Cerra, vice president of the academic health center, was designed to let lawmakers know 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.

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

While research already has 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.