A product made using human skin cells won support Monday from federal advisers for helping to heal hard-to-treat diabetic foot ulcers that lead to tens of thousands of amputations each year.
The product, known as Apligraf, is manufactured by Canton, Mass.-based Organogenesis Inc by taking cells made available from infant circumcisions. Scientists combine the living human cells with collagen from cattle to manufacture a product that looks and feels similar to human skin. The product is shipped with a supply of nutrients to help keep it alive.
Apligraf, which is marketed by Novartis AG, has been sold in the US market since 1998 for treating leg ulcers caused by circulatory problems.
Now, the companies are asking the Food and Drug Administration to allow promotion of Apligraf for diabetic foot ulcers, which afflict between 600,000 and 800,000 US diabetics each year.
The FDA usually follows its panels' advice.
After reviewing a clinical trial of 208 diabetics, the FDA advisory panel unanimously recommended that the FDA approve Apligraf for treating diabetic foot ulcers after standard treatment had failed.
Normally doctors treat the ulcers by cleaning them, applying wound dressings and asking patients to keep weight off the foot. But those measures have been limited. About 1,000 US diabetics undergo limb amputations each week because of ulcer infections or other complications.
In patients treated with Apligraf and the standard care, 56 percent had complete wound closure 12 weeks after initial treatment. That compared to 38 percent of a control group given the standard care alone, Organogenesis said. More than 80 percent of the ulcers remained closed after four weeks for both groups.
Side effects, including wound infections, occurred at similar rates for Apligraf and the control group.
``Apligraf provided effective treatment and did not pose an increased risk'' of side effects, said Dr. Michael Sabolinski, senior vice president for medical and regulatory affairs at Organogenesis.
Panel members said they were convinced that Apligraf provided some benefit, although they said flaws in the study's design prevented them from discerning exactly how much it helped.
``There is an effectiveness, but there is some question of degree,'' said Dr. Thomas Whalen, the panel's chairman and the head of pediatric surgery at the Robert Wood Johnson Medical School in Camden, New Jersey.
Winning FDA approval for treating diabetic foot ulcers with Apligraf would be an important milestone for Organogenesis, said president and chief executive officer Philip Laughlin. Apligraf is the leading product for the company, which is working to develop other products in the emerging field of engineered tissue and organs.
``It's a big deal for us,'' Laughlin said. ``Diabetic foot ulcers are viewed as a much more serious need'' than the leg ulcers Apligraf now is approved to treat.
Organogenesis receives royalty payments from Novartis for developing and marketing the product. Novartis declined to provide Apligraf's sales figures for last year.
Other companies have suffered setbacks trying to market treatments for diabetic foot ulcers. The FDA rejected an antibiotic cream called Locilex, developed by Magainin Pharmaceuticals and required a new clinical trial to evaluate Advanced Tissue Sciences' product, Dermagraft.