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Blood Substitute Hemopure Approved for Use in Human Patients

(Originally posted 28 May 2001 on About Anesthesiology)

Hemopure, a blood substitute product from Biopure Corporation, has recently been approved for marketing and use in adult patients in South Africa. The product has the specific indication of acute anemia related to surgery. This is the first blood substitute to be approved in any country for general use.

Hemopure is a product that is made from highly purified bovine blood and only claims to provide a form of hemoglobin to assist in the delivery of oxygen to end organs and tissues. It does not substitute otherwise for blood - meaning that it may not improve hemodynamics in many cases. In addition, it differs from blood in that it has a shorter circulation time (only one or two days).

Hemopure does not require refrigeration, so it can be kept readily available for use in the operating room. In addition, the company claims that there is no risk for infection with this product. The manufacturing process removes or inactivates viruses, including HIV and hepatitis C.

In addition, some have been concerned because this is a product that comes from cows; the recent highlights on bovine spongiform encephalopathy (mad cow disease) has brought this issue to the forefront. However, the company states that this is not an issue or risk with this product, again because of the purification process.

Hemopure has been found to be acceptable for use for Jehovah's Witnesses, a group of patients that refuse the transfusion of human blood products for religious reasons. Other clinical applications remain to be determined as the product becomes available and further studies are done.

The product should be available in South Africa beginning in early 2002. The company plans to file for approval in Europe and the United States prior to the product's release in South Africa. They base their regulatory filings on over twenty clinical studies conducted in many countries.


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