My beef with Cytori is that the company seems disinterested in running real clinical studies. Instead, the company supports pseudo-studies that produce marketing pitches instead of scientific data. This strategy isn't helping Cytori, either. The company struggles to sell the Celution Systems device in Europe and Japan (witness the disappointing results from the first quarter) and doesn't appear to be making any headway with reimbursement. Cytori's efforts at gaining any regulatory approval at all in the U.S. also have been stymied.
I asked Cytori to explain why the company does not support controlled studies of stem cell-enriched fat, including the physician-sponsored study mentioned above.
"Generally speaking, when no generally accepted therapy exists, showing improvement in single arm prospective trials is the next best alternative to a controlled trial," said Cytori spokesperson Megan McCormick.
She added, "In this case, the medical literature supports the fact that there is no standard of care for lumpectomy reconstruction. That is perhaps why this physician chose not to incorporate a control arm. Additionally, ethical, statistical and logistical issues effectively prohibit comparative studies planned to test two experimental treatments against each other."My response to McCormick (admittedly somewhat snide but still on point) was that perhaps the U.K. physician chose not to use a control arm in his study because his hospital purchased an expensive Celution System device and needs to recoup the investment. The doctor might be afraid that if he performed a regular and relatively inexpensive fat graft, he'd find the outcome to be the same as one using the more expensive Cytori "enhanced" stem cell-fat graft. On a more serious note, Cytori's assertion that a controlled study would be ethically or logistically impossible is not shared by leading plastic surgeons. I covered this ground last May in an interview with Dr. Karol Gutowski, a plastic surgeon affiliated with the University of Chicago and chairman of a 2009 task force of the American Society of Plastic Surgeons that examined the safety and efficacy of fat grafting procedures. "The patient satisfaction data [from Restore 2] are meaningless without a comparison to an alternative (or no) therapy. It's like asking a kid, how much do you like ice cream? Compared to what?" said Gutowski last May. [Restore 2 is another breast reconstruction study using stem cell-enriched fat grafts that was conducted by Cytori.]
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