The use of stem cells from human embryos is notorious for unleashing a political storm. But it's the use of stem cells from human adults that is posing the most immediate challenge for policy-makers.
In August, for instance, Health Canada approved the sale of a medical device to extract stem cells from human fat tissue. It gave Cytori Therapeutics Inc. of California licences that would allow its Celution System machine to be used to collect stem cells for the purpose of reinfusing them in the same patient “in plastic and reconstruction procedures.” The machines are used in unproven cosmetic procedures in certain European and Asian countries.
But Health Canada cancelled the Cytori licences on Nov. 5 because it discovered that the biological agents needed to operate the machines and process the stem cells had not received regulatory approval. If and when that approval goes ahead, says Health Canada spokesman Gary Holub, the use of stem cells in cosmetic procedures would be permitted only as part of an authorized clinical trial.
Yet cosmetic surgeon Sammy Sliwin, who is eager to make stem cells part of his Toronto practice, says Health Canada officials have told him that no such trial would be necessary because the stem cells belong to the patient, so long as they are “minimally manipulated” and reinjected into fat, the same type of tissue they came from.
He has already flown to California to be trained on the Cytori machine.
In the U.S., the Food and Drug Administration has yet to approve the Cytori machine. But some doctors have not waited for approval. This summer, the FDA applied for a court injunction to stop a Colorado clinic from using patient-derived stem cells to treat fractures, torn tendons and other ailments.
The Regenerative Sciences clinic is fighting the order. The company offers the treatment with the idea that the patient's stem cells have the potential to grow into healing fat, bone or cartilage at an injury site and reportedly charges up to $9,000 (U.S.).
While the FDA argues that neither safety nor efficacy has been proved, the clinic's medical director, Christopher Centeno, has argued that a procedure involving a patient's own cells – as with in-vitro fertilization – is no business of the FDA.