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However, the devices used in these trials were made with a manufacturing process that is only appropriate for growing small batches of cells. To run the larger clinical trials required for approval by the FDA and to supply needy patients if the device is approved, RenaMed will need to find a way to make and deliver the device on a much larger scale.

When growing cells for therapies, scientists must create a robust protocol that reliably produces the target cell, as well as quality-control measures to keep the process on track. “People in academic labs develop techniques based on their own green thumbs at the bench,” says Michael Lysaght, a tissue engineer at Brown University, in Providence, RI. “But there’s a totally different culture when it comes to producing things for the FDA. Every step has to be understood and extremely well documented and capable of being done by anyone.” In addition, he says, the safety and reproducibility testing required by the FDA is much more rigorous than that needed for pilot clinical trials.

Both Humes and Lysaght liken the problem to that faced twenty years ago by researchers working with recombinant proteins, such as human insulin. Scientists could successfully make the proteins in the lab, but it took several years to figure out how to scale up that process for broad medical use. Lysaght says he’s confident the same will be true for tissue-engineered products once people recognize the extent of the problem.

If RenaMed can clear the hurdle, it may be able to lead the way for other bioengineered devices. “If there ever was a fair-haired child in tissue engineering, it was this device,” says Lysaght. “Everyone is hoping it will be a big success.”

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