How does a 110-year-old medical device company end up on the cutting edge of regenerative medicine? The answer: A little innovation and a lot of persistence.
That formula paid off this week for Holliston, MA-based Harvard Bioscience (NASDAQ: HBIO). On Monday, the company announced that a product it makes called the InBreath Bioreactor was featured in an article in the prestigious peer-reviewed medical journal The Lancet. The article described the world’s first implantation of a synthetic trachea, which was made in the bioreactor using the patient’s own stem cells. The next day, Harvard Bioscience announced that the second synthetic trachea—also made with the InBreath—had been successfully implanted. “This is a big breakthrough at a time when there is not enough supply of donor organs,” says Harvard Bioscience’s president David Green.
For most of its long history, Harvard Bioscience has been known as a solid but relatively sleepy maker of scientific instruments, such as pumps and glassware used by drug researchers. The company markets 16 different brands, and last year it posted $19 million in profits on $108 million in sales.
In 2008, Green says, Harvard Bioscience started working with Massachusetts General Hospital on technology that can be used to grow lungs outside of the human body. Around that time, Green read a paper in The Lancet describing how physicians in Italy transplanted into a patient a new trachea that they constructed partially from donated tissues and partially from cells taken from the patient.
Green wanted to expand Harvard Bioscience’s presence in regenerative medicine, so he e-mailed the lead author of that paper, an Italian physician named Paolo Macchiarini, and expressed an interest in licensing the technology used to grow the trachea. The licensing agreement was sewed up in August 2009, and Harvard Bioscience got to work refining the technology.
The tracheas used in the two surgeries announced this week, both of which were performed by Macchiarini, were made slightly differently. The first patient—36-year-old Andemariam Beyene, who was suffering from inoperable tracheal cancer—received a tracheal scaffold made from”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.”