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Blood Substitutes Artificial Blood Synthetic Alternatives to Donor Blood Have Been Stuck in Development for Decades

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Blood Substitutes Artificial Blood Synthetic Alternatives to Donor Blood Have Been Stuck in Development for Decades Blood substitutes Artificial blood Synthetic alternatives to donor blood have been stuck in development for decades. Nina Notman reports on recent promising progress Human blood substitutes have been blood reserves, says Chang. More could be contaminated, companies in the pipeline since the 1980s. But, niche needs include patients, such In short started to make many different for a combination of scientific and as Jehovah’s Witnesses, who for The HIV crisis in the types of blood substitutes, and political reasons, there are none religious reasons can not use donor 1980s triggered research unfortunately some don’t work and currently on the market in either blood, and patients who have into artificial blood some have adverse side effects.’ Europe or the US. There are a few developed immune responses to Obtaining regulatory The concerns came to a head in blood substitutes still progressing donated blood. approval for these early 2008, when a meta-analysis through clinical trials, and the Aside from not being reliant on products has proved of findings from 16 clinical trials academic community is still actively donor blood supplies, other major difficult so far in Europe of five different products that had improving the products, also advantages of artificial blood include and the US been used on over 3500 patients known as oxygen therapeutics and not needing to check blood types Commercial design was published in the Journal of haemoglobin-based oxygen carriers. before transfusion – artificial blood approaches include the American Medical Association. ‘No one was interested in this type is the universal blood group O leaving haemoglobin free The study, led by Charles of work until HIV came in the 1980s,’ negative. Artificial blood also avoids in plasma, and encasing Natanson, a senior scientist at the explains Thomas Chang from McGill shelf life issues – donor blood can it in artificial, polymeric US National Institutes of Health, University, Montreal, Canada, an be stored for a maximum of 42 days red blood cells revealed a threefold increase in early pioneer of the field, ‘and then before use, and starts to degrade in The academic the risk of heart attacks in patients everyone started to look into making quality shortly after collection. community is working who received the substitutes, artificial blood substitutes.’ on bettering the basic compared with the control group He adds, ‘we have to be ready Outsmarting obstacles understanding of how who received donor blood (see for another HIV episode or The need and utility may be clear, but blood works, to further Chemistry World, June 2008, p13). similar when the blood might be the route to regulatory approval in improve the products ‘The paper by Natanson contaminated.’ It was HIV concerns Europe and the US has been tortuous combined the results of all the that led to South Africa becoming – with numerous hurdles seemingly clinical trials, of all the products, one of the few countries so far to intent on blocking the way. from all the companies, and lumped approve the use of a blood substitute The first clinical trials for them together,’ says Chang, ‘and – a product called Hemopure. these products – run by a number that was a disaster for this field.’ Fears of contaminated donor of different companies – had Some of the products had fewer blood supplies are just one reason disappointing results with some side effects than others, but for the interest in this area. Ongoing unwanted side effects, most because they were treated as one concerns about lack of donor blood seriously an increase in blood everyone started to worry and the supplies in remote locations are also pressure. Chang blames the results US Food and Drug Administration driving the field forward, with the on a rush to get a product to market (FDA) became reluctant to approve US army and navy funding much in the wake of the HIV crisis: ‘not anything, he says. of the research. You never know enough basic research was done Chang’s frustration is shared when there will be a disaster or prior to HIV – and as a result, when by many scientists working in the war when we won’t have sufficient it was realised that donor blood field, including John Olson, based 40 | Chemistry World | October 2010 www.chemistryworld.org TEK IMAGE / SCIENCE PHOTO LIBRARY LIBRARY PHOTO SCIENCE / IMAGE TEK www.chemistryworld.org Chemistry World | October 2010 | 41 Blood substitutes a very consistent finding no matter ‘Like everything what type of patients you were looking at or which of the various OPK BIOTECH OPK in science, it is how you companies you looked at, he adds. package Hemopure Although the FDA is currently the data for wary of these products, a handful presenting’ of companies in the US are still working their way through the obstacles in the attempt to get a blood substitute to market. According to Olson, the best of the bunch is Hemopure – a blood substitute being developed by the oxygen therapeutics firm OPK Biotech. Hemopure was initially designed by the small start up company Biopure, which was brought by OPK Biotech when it went bankrupt last year (see Chemistry World, 14 May 2009, The haemoglobin in OPK bit.ly/4kdkEn). Biotech’s Hemopure ‘Hemopure is the one, in my is stabilised by opinion, that should be closest to polymerisation being approved for use when no donated blood is available,’ Olson at Rice University, Houston, US: Natanson, however, stands by his says. ‘It is the simplest and the ‘the Natanson article says every findings: ‘meta-analysis showed that cheapest technology.’ blood substitute is evil and causes if you put all the studies together As Rick Light, vice president of heart attacks. But like everything in there was a very common toxicity – research and development at OPK science, it is how you package the that is they appeared to cause heart Biotech, explains: ‘an important data for presenting.’ attacks and death.’ It appeared to be distinction between Hemopure and any other haemoglobin-based oxygen carrier is that Hemopure is Blood pharming room temperature stable as a liquid Another potential route to blood substitutes is to director of research and development. for at least 3 years.’ You just pull it off grow human red blood cells from cells extracted The first step is to isolate haematopoietic the shelf and use it immediately, he from umbilical cords – a technique called blood stem cells from an umbilical cord. ‘We then says. This stands it apart from other pharming. culture those on our Nanex technology, which is potential blood substitutes that One biotechnology firm exploring this a polymer nanofibre substrate that expands the need refrigeration, or are freeze- approach is Arteriocyte, based in Cleveland, US. stem cells much more rapidly than normal cell dried, meaning they have to be ‘We have demonstrated proof of concept that culture techniques,’ Sorkin explains. ‘In 10 days reconstituted with plasma. we can take umbilical cord cells, expand them we get a 300 to 350-fold increase in cells and To make Hemopure ‘we take and differentiate them [into red blood cells] in over a month we can get hundreds of thousands, bovine blood and, using filtration useful volumes,’ says Adam Sorkin, Arteriocyte’s or a million-fold increase.’ and chromatography, purify the The second stage is to recreate the haemoglobin so it is 99.9 per cent differentiation process that occurs normally pure protein,’ explains Light. in the body, in vitro. ‘Using a special cocktail of But sadly it isn’t as simple as just growth factors that we change over the course dissolving the haemoglobin in a fluid of several weeks, we gradually drive most of and transfusing it into the patient. these stem cells to form red blood cells that Native haemoglobin is tetrameric are functionally indistinguishable from the red and dissociates into dimers in the blood cells you would produce natively.’ body that are excreted through the Finally, the cells are filtered and put in plasma kidneys with a half life of about or fluid before they can be transfused directly 30 minutes. ‘Which is not a very into the body. effective therapy,’ Light points out. The end goal is to carry out the complete ‘You have to modify the haemoglobin process onsite in remote areas such as in so it doesn’t dissociate.’ hospitals in war zones. ‘Once it’s up and running, A number of different approaches the idea is that it will be producing universal have been taken to stop this donor blood on demand,’ says Sorkin. dissociation. ‘What we do is ‘What we are working on now is implementing polymerise with glutaraldehyde the bioreactor technology that will handle the [pentane-1,5-dial] to make large differentiation step. At that point we would polymers of haemoglobin that have ARTERIOCYTE move into [clinical] trials.’ Sorkin predicts that it a half life of between 18 and 24 hours Arteriocyte’s Nanex polymer nanofibre substrate will take another 5–10 years for this product to in the body,’ Light says. for rapid stem cell culturing reach the market. The polymerised haemoglobin is then put into a physiological buffer, 42 | Chemistry World | October 2010 www.chemistryworld.org which contains salts and lactates to maintain heart function. At this stage the product still contains about 30 per cent stabilised haemoglobin tetramers – and while they may not dissociate in this form, they are still problematic because they can enter blood vessel walls and scavenge nitric oxide. NO naturally causes the walls of blood vessels to relax, so if too much NO is scavenged, relaxation is prevented, making it more difficult for blood to flow, resulting in an increase in blood pressure.
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