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“rubbery” nanomaterials, Green says. Stem cells were taken from the patient’s bone marrow and grown on the scaffold for two days. No donor tissue was necessary, and because the patient’s cells were used, he didn’t need to take the “immunosuppressive” anti-rejection drugs that organ-transplant patients normally get. The surgery took place in June at Karolinska University Hospital in Sweden.
In the second surgery, performed November 17 at Karolinska, 30-year-old cancer patient Christopher Lyles from Baltimore received a trachea made in the InBreath device. This time, Green says, the scaffold was constructed using a “fibrous material spun like thread.” After the scaffold was seeded with cells from Lyles’ bone marrow, blood vessels grew into it quickly, Green adds. “It was a much more porous structure and further along in the process of becoming tissue,” he says.
Both patients are doing well and have not needed immunosuppressive drugs, Green reports. He believes that’s a big reason the idea of growing replacement organs using patients’ native cells should catch on in the medical community. “Immunosuppressive drugs have a negative impact on patients,” says Green, who points out that the drugs not only cause side effects but they can also be expensive. “They cost $10,000 to $20,000 a year,” he says. “Using patients’ own cells removes that burden. And the scaffolds can be manufactured in a factory.”
Harvard Bioscience has a ways to go before it can think about mass-marketing organs made in the InBreath device, though. The artificial-trachea procedure has not yet been approved in the United States. Two patients are being considered for U.S.-based tracheal transplants using the company’s technology—one a baby born with a hole in her esophagus, the other a ballerina with a genetic deficiency that affects her trachea—but the FDA has yet to give the green light.
And stem-cell-based technologies have proven to be a regulatory headache for other companies. Most recently, on November 14, Menlo Park, CA-based Geron (NASDAQ: GERN) announced that it was getting out of the business of developing embryonic stem cell therapies. The company, which suffered multiple delays getting its first treatment into clinical trials, cited cost as a major concern.
Green says the safety profile of stem cells taken from patients’ own bone marrow is better than that of embryonic stem cells from donated embryos. And he’s confident the two tracheal surgeries announced this week will help build confidence in such procedures. The first patient, he adds, has been free of cancer for five months and returned to graduate school. “When you have two living, breathing success stories, Green says, “it’s hard to be critical of the field of regenerative medicine.”