Artificial blood is edging a step closer to everyday use.
Baxter International recently won FDA approval to begin clinical testing of an experimental blood substitute in trauma patients. It's the first blood substitute ever to advance this far in the testing process.
Deerfield, Ill.-based Baxter has yet to finalize arrangements with the 20 or so trauma centers expected to participate in the trial of the product called HemAssist. But the study, involving about 850 patients, could start as soon as next month, the company said.
Blood substitutes promise an answer to periodic shortages of blood supplies by offering extended shelf-life, freedom from matching problems and reduced risk of infections. Baxter estimates the combined annual U.S. and European market for blood substitutes at $2 billion to $4 billion.
If the study goes as expected, Baxter said its artificial blood could be available for trauma use in Europe by 1998 and in the United States the following year.
But previous blood substitutes were stymied early in development, forcing companies to go back to the drawing boards. And even current artificial blood products with clinical promise have been dogged by questions that their costs outweigh their potential benefits, analysts say.
Although Baxter hasn't determined how much HemAssist would cost, if the FDA approves it the company said it would not be less than standard blood.
The start of Baxter's trauma study has been complicated by special steps needed to protect patient rights. Potential study subjects would be unlikely to be able to grant consent due to their life-threatening injuries.
"Patients have to be in shock to qualify," said Mark Cipolle, M.D., a trauma specialist at Lehigh Valley Hospital in Allentown, Pa., one of the expected study centers.
Until recently, studies of such products in patients without prior consent were all but impossible. But FDA regulations were eased in October. Earlier this year, Baxter also started a widespread clinical study of the product in elective surgery.
In the trauma study, Baxter will test whether its blood substitute reduces death rates in patients in shock from blood loss, the company said. One patient group will receive saline solution to initially stabilize their blood pressure while another will receive the Baxter product.
Baxter's blood substitute is manufactured from expired human blood and relies on chemically processed hemoglobin, the iron-rich protein in red blood cells that carries oxygen throughout the body.
A well-known skeptic of artificial blood's commercial viability questioned whether Baxter's attempt to reduce death rates in a narrowly defined patient group jibes with its market estimates for artificial blood.
"It's a salvage indication that applies to very few patients right now," said Paul Kelly, an industry analyst with UBS Securities in New York. "If Baxter is going to develop a multibillion-dollar market in trauma, this is an awfully small step."