Canadian stem cell trials impeded by federal regulations: doctors

When a Swiss-based researcher announced this month he had achieved some improvement in profoundly paralyzed spinal-cord-injury patients with an injection of stem cells, he generated headlines worldwide. Dr. Armin Curts findings were the first evidence from actual humans though far from conclusive that the much-hyped stem-cell concept might work in paraplegic and quadriplegic patients.

What went unsaid was that the breakthrough could have taken place in Canada.

Dr. Curt, then working in Vancouver, and Dr. Michael Fehlings, a Toronto-based leader in the field, had earlier proposed that the clinical trial be conducted here. Federal regulators, however, are essentially standing in the way of studying stem-cell treatments on spinal-cord patients, insisting that promising results achieved in rats and mice be first replicated in monkeys or apes, the two researchers say.

Such non-human primate studies would be extraordinarily costly, highly time-consuming and ethically challenging, said Dr. Fehlings, medical director of the Krembil Neuroscience Centre at Toronto Western Hospital. And he said little would be gained by conducting them.

It probably would have delayed the field by another 10 years, said the neurosurgeon. When you think about a condition as serious and life-threatening and damaging as spinal cord injury is that a reasonable bar, or is that setting the bar at a level that is not appropriate?

Canada appears to have set itself apart from regulators in Europe and the United States, who have recently approved human stem-cell trials without primate studies first, said Dr. Fehlings.

It is a challenge and an additional kind of burden to the stem-cell researchers in Canada There is such a roadblock

He said he does not want to put Health Canada on the hot seat but would like to see the various international jurisdictions jointly hammer out guidelines that help human study move ahead quickly.

The need is urgent, especially since many patients from Canada and elsewhere are spending large sums and facing real danger by seeking out dubious stem-cell treatments in places like China, he said.

Health Canada is prevented by privacy rules from commenting on any specific application for approval of a clinical trial, said Sean Upton, a spokesman. He said the regulator does not have a formal policy or rule requiring primate studies, but each application for approval of a clinical trial is judged on its own merits.

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Canadian stem cell trials impeded by federal regulations: doctors