Experts: Stem cell research ban could make criminals out of patients

A bill in the Minnesota Legislature that would ban some forms of stem cell research could have unintended consequences for patients and researchers if it becomes law. The Human Cloning Prohibition Act could cost the Minnesota biotech industry millions in lost research dollars and sales, and the bill could potentially turn certain stem cell patients into criminals if they return to Minnesota after receiving certain treatments outside the state.

Dr. Hans Keirstead of the University of California Irvine is in negotiations with the Food and Drug Administration to conduct the first ever trials using embryonic stem cells to improve function in people with spinal cord injuries. While the therapy is promising, patients will also have to take anti-rejection drugs to prevent the body from attacking the stem cells. But Keirstead has another plan: Use somatic cell nuclear transfer (SCNT) to create stem cells out of the patients’ own cells, ensuring that their bodies won’t reject them. In California such research is legal even though human cloning is expressly banned; legislators in Minnesota want to make that research a crime along with human cloning.

Keirstad and his research teams are pioneers in the field of stem cell research. They found a way several years ago to program stem cells to replicate as neural cells — the kind damaged in spinal cord injuries — at a high rate of purity. The embryonic stem cells his lab created are from existing stem cell lines which were created from discarded embryos from fertility clinics.

Those stem cells won’t match spinal cord injury patients’ own cells, and their bodies will reject the cells unless they take long-term courses of drugs to prevent their own immune system from attacking what could be an effective treatment.

Using SCNT, Keirstad hopes to create stem cells that match each individual patient. By taking cells from the patient’s skin or other part of the body and injecting them into a human egg, researchers can create stem cells that match the patient perfectly.

That’s what Minnesota’s proposed bill would criminalize, and it’s what the anti-abortion rights group Minnesota Citizens Concerned for Life calls “human cloning.”

But the bill goes even further as Sen. Ron Latz (DFL-St. Louis Park) noted in Monday’s Higher Education Committee meeting.

Criminalizing patients?

“This bill makes it a crime not only to engage in that particular form of scientific conduct, but also to ship or receive or import any aggregation of cells that would meet this definition including, I suppose, if a person were to travel out of state and receive therapy that was created… created using this method of science and attempt to return to the state would be guilty of importing those cells and committing a crime simply by coming to Minnesota,” he said.

The Minnesota Independent spoke with several experts to ascertain if that would indeed be the case.

“Laws have been interpreted that way, but it’s a matter of opinion the courts will have to decide,” said Don Gibbons of the California Institute for Regenerative Medicine. He added that it’s hard to say for sure, since it’s up to law enforcement and the court system to determine application of the law.

Asked if the bill would criminalize travel into the state by patients participating in SCNT research, Michael Werner of the Washington, D.C.–based Alliance for Regenerative Medicine, said, “Well, it certainly could. This type of bill doesn’t account for a number of variables.”

“We don’t know where the next scientific discovery is going to come from whether it’s induced pluripotent stem cells, embryonic stem cells, umbilical cord cells or SCNT.”

He gave a scenario where a researcher might use SCNT to develop a certain kind of cell, and then that cell was altered or refined to create a treatment for a specific disease.

“Would that treatment still be a considered a product of SCNT?” Warner asked. “How many steps removed does the product stop being SCNT-derived? What if this technology led to other discoveries would treatments devired from those discoveries be available?”

He added, “The process of scientific discovery builds on itself.”

Lost research dollars

Dr. John Wagner of the University of Minnesota’s Stem Cell Institute told members of the Senate Higher Education Committee that the bill could cost the state in lost research funding.

“I think that, to be conservative, on the cheap end, would be hundreds of millions of dollars. There is a lot of work to get there, but the potential is massive,” he said.

Those numbers are in line with what market experts estimate. In one study in the publication Regenerative Medicine Cell Therapies, cell-based research alone generated millions in 2010. “We estimate from the cumulative numbers of units manufactured and patients treated as well as from discussions with senior industry experts, that the current value of the regenerative medicine cell therapy market is presently in the order of $100–200 million per annum,” the report’s authors wrote.

A 2010 memo from MaRS Advisory Services, a market research company based in Canada, stated that “2009 estimates approximate that the stem cell market (including blood cord banking and drug development tools) will achieve an annual growth of 29.2% resulting in sales of $11 billion by 2020.”

None of the organizations contacted by the Minnesota Independent would offer an estimate of how much a ban on SCNT would cost Minnesota in the long-term.

If passed into law, the ban could also mean top researchers leave the state to work at universities where such research is permitted. “I’ve been approached by Stanford,” Wagner said. “The California Institute for Regenerative Medicine is putting out an RFA to recruit people from other states.”

Sen. Latz asked him if that was before or after the bill was introduced.

Wagner responded, “Both.”

Huge potential

SCNT has not yet been successful in the lab, but there’s a consensus among stem cell researchers that it has huge potential.

A working group of stem cell researchers from around the world met last summer to discuss the future of the technique and they concluded that the research is vital:

Given that our knowledge of reprogramming is in its infancy, it is still possible that hSCNT will emerge as the technology of choice for specific human stem cell therapies or for developing particular disease models. A further reason to continue hSCNT research rests in its potential to shed light on the earliest stages of human development. Even the first few events after fertilization differ among species (Haaf, 2006), and increasing evidence suggests that subtle defects in these early stages of development can have serious repercussions on health and viability (Reefhuis, et al., 2009). Although some of these events can be studied using other in vitro models, hSCNT could be particularly useful for understanding the influence of genetic background on early development and help us understand environmental and genetic contributions to developmental disorders.

Because of that potential, the Minnesota Medical Association and the University of Minnesota have come out strongly against the proposed bill.

The bill — sponsored by 31 House Republicans and three House DFLers and five Senate Republicans — passed through key committees in both chambers within the past week and currently awaits a vote on the Senate floor.