When children with the spine malformation, spina bifida, develop a serious bladder failure, they have one, somewhat unsavory, option. In a 10-hour procedure, a surgeon enlarges the bladder using a piece of the patient's intestine. It usually works, but there are several risks including occasional rupture of the rebuilt bladder and possibly cancer.
East Norriton, Pa.-based Tengion, would like to offer a better option, says Gary Sender, the company's chief financial officer. Tengion is developing a regenerated bladder, a new organ grown from the patient's own cells. Sender says there will be a series of products from his 85-employee company, which is applying the same concept to different organs.
The private company holds about 70 patents, most licensed from Children's Hospital Boston, covering products with "excellent intellectual property protection," Sender says. Translation: he sees no serious threat of competition in the regenerated-organ niche. Tengion has raised more than $100 million from several venture capital firms.
If Tengion dominates the nascent regenerated-organ business, it can thank its founding scientist, urologist Anthony Atala of Wake Forest University School of Medicine in Winston-Salem, NC. Atala heads the scientific advisory board for Tengion, whose work has largely consisted of refining and scaling up the process, says Tim Bertram, senior vice president, science and technology, at Tengion.
The technique consists of obtaining a small number of a patient's bladder cells, which are then put in a precisely ordered fashion on a special bladder-shaped polymer scaffold and left to grow for seven or eight weeks. A surgeon then implants the device in the patient's body, where the scaffold degrades and the regenerated bladder takes over its duties. Creating the new organs is "a labor-intensive and costly process," says Bertram. The company won't reveal the cost, but it's betting they'll be safer and more effective than the currently used surgery: augmentation enterocystoplasty, a modernized form of a procedure developed in the 1880s.
In early January 2007, Tengion launched its first Phase II clinical trial of a regenerated organ, implanting its "neo-bladder construct" in children with spina bifida. By mid-September of the same year, it launched a second Phase II trial of the same implant, this time in adults with bladder failure due to spinal cord injuries. Sender declined to disclose any early results, but he says nothing has happened to dampen confidence in the product.
Bertram says the neo-bladder implants could replace at least some of the roughly 10,000 bladder reconstructions now performed annually nationwide. Conditions including spina bifida, multiple sclerosis, and spine injuries give rise to the need for such operations.
In coming years, Sender says, "other people will be designing tissues and organs based on a patient's cells, but we believe we're a generation ahead."
Editor's note: For more information about Tengion and its autologous bladder technology, see the December 2007 issue of The Scientist