South Africa Approves Blood Substitute

A product that can emulate the work of red blood cells, transporting oxygen throughout the body, has been approved for use in South Africa, making it the first human “blood substitute” available anywhere in the world, the product’s developers announced Tuesday.

Hemopure, a solution made from cow hemoglobin, has a longer shelf life than blood, does not carry the same risk of disease as unscreened blood and can be administered to any person, regardless of blood type, said officials of Biopure, the U.S. company that developed the product.

“Every unit of blood you get is different, whereas ours is a consistent, reproducible, pharmaceutical-grade product,” Biopure chief executive Carl Rausch said.

However, some independent medical experts said Hemopure was not a substitute for blood but simply an effective temporary treatment until safe blood could be found.

“This is an excellent place holder for supporting people in acute care situations, which is injury or surgery. It is not good for maintaining people long term,” said Dr. Rebecca Haley, the chief medical officer of the American Red Cross’ biomedical service.

Biotechnology companies have been working for nearly two decades to create oxygenating products, and at least three other companies are in the late stages of product development. South Africa was the first country to approve Hemopure because its approval process moved faster than others, Rausch said.

Biopure plans to file an application this year for approval of Hemopure in the United States and Europe. It has already received approval in the United States and Europe for a different blood substitute for dogs.

South Africa’s Medicines Control Council approved Hemopure April 9 for use only as a blood replacement during surgery, but the product could have far greater applications, Rausch said.

Its oxygen-carrying particles are 1,000 times smaller than red blood cells, allowing them to flow past blocked arteries and into tumors, where the increased oxygen can assist in radiation treatments for cancer, he said.

The solution would eliminate the risk of catching infectious diseases--including HIV--from tainted blood transfusions, Rausch said. Donor blood must be refrigerated and can be stored only for 42 days, while Hemopure can be stored at room temperature for two years.

Hemopure is made using hemoglobin from the blood of U.S. cows that have been closely monitored to ensure they are disease-free, Rausch said. The blood then has all its proteins removed and is purified to prevent the transmission of bovine diseases, including mad cow disease, he said.

Though researchers have raised fears that medical products made from animals could introduce new diseases to people, health professionals said they were more concerned that Hemopure’s usefulness was being overstated.

“It certainly is not going to replace blood transfusion by any means,” said Dr. Anthon Heyns, chief executive of the South African National Blood Service, which controls the majority of the country’s blood supply.

Whereas transfused blood can effectively transmit oxygen for about a month, Hemopure loses its effectiveness in a day or two, requiring far more transfusions. The solution would act only as a bridge, helping keep patients healthy until real blood can be located, Heyns said.

Hemopure also does not give the body the platelets and plasma that donated blood provides, he said.

However, in developing countries with shortages of safe blood, Hemopure could be an important substitute for transfusions, said Dr. Luc Noel, coordinator for blood transfusion safety at the World Health Organization in Geneva.

“If there is any alternative that is safer than the potential risks of transfusions, then it should be used,” he said.

Hemopure’s side effects include slightly increased risk of stomach pain, weakness, hypertension, jaundice and nausea. But its problems are no greater than those associated with regular blood transfusions, Biopure officials said.

In the United States, Hemopure is expected to be four to five times more expensive than blood, Haley said. Hemopure’s local distributors said they had not yet determined a price for South Africa, but it would be less than the cost in wealthier countries.