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T O P I C     R E V I E W
jackbequick  - posted
This might be why...Intrepid Medical Technologies..Is so interested in Protokinetix's research on Blood Storage, using it's molecule..AAGP. A good read..

This article is great, in showing how PKTX will change the way the world will store blood, which will be better for mankind...

..Blood platelets are a blood product called coagulants. They clot blood and thus prevent people from serious bleeding and often fatal blood loss.
..Blood platelets have a shelf life of 4.5 days and then discarded because of bacterial contamination.
..If blood platelets are refrigerated they go into coagulation and cannot be used.

..Laboratory tests have shown that when AAGP™ is used with blood platelets they can be stored at refrigeration temperatures without coagulation.
..The shelf life can be extended to 21 days and more. The amount of blood platelets available for patients can now be increased five-fold without increasing the donor base.

..For approximately 40 years before the HBS platelet preservation technology was developed, companies and individuals tried without success to preserve platelets using various methods. Platelets, the tiny congealing component of blood, are extremely sensitive to cold and heat.

..At the hospital level, there is an annual total of approximately one billion dollars in lost revenue from outdated and discarded platelets. This loss is comprised of approximately 20% of all processed platelets from North America, Europe and Japan. The limited shelf life for platelets stored at room temperatures creates a variety of problems including less efficient platelet performance and bacterial damage, which can be dangerous to the recipient.

..The primary use of blood platelets is for cancer patients undergoing chemotherapy treatment. The process of chemotherapy temporarily destroys the body's ability to produce platelets. Cancer patients frequently have compromised immune systems, so bacterial infections in platelets present a significant risk to this group.

..To ensure the safety of blood and blood products, FDA-required testing must be conducted following collection, cutting into the platelets' viable life cycle, but critical to control infected blood. Platelets collected on a Friday must be processed, tested, inventoried and delivered. However, by Monday their functional life is nearly over. Without sufficient time for testing, inventory management and transportation, platelets frequently spoil before there is an opportunity to infuse them.

..Using our breakthrough technologies, our HBS goal is to provide effective and inexpensive solutions to these problems and simultaneously could recover up to 90 percent of revenues that would otherwise be lost.

..A Proprietary Non-toxic Preservation System
Our innovative preservation method employs no preservatives or cryogenic techniques. It combines the platelets with a non-toxic solution comprised of infusible liquid materials.

..Simple to Use, Operate, and Maintain
Simple protocols including industry-specified labeling make it easy for blood centers to adapt our products to their present system.

..Economical and Profitable
Amazingly, blood centers and hospitals worldwide lose an estimated one billion dollars in revenue annually due to discarded platelets. In 2002, it is estimated that more than 1,000,000 units of spoiled platelets were discarded in North America, Western Europe, and Japan. As platelets represent the single most profitable blood component sold by blood centers, the ability to extend platelet shelf life and recoup revenue forfeited through spoilage would significantly improve the centers' profitability. Extending the preservation time from five to 10 days may allow blood centers and hospitals to recover up to 90 percent of revenues lost due to outdating.

The Human BioSystems' biological preservation program is a technologically advanced preservation and storage system intended to extend the shelf life of platelets, the congealing component of blood. Cancer patients undergoing chemotherapy treatments are the predominant recipients of platelet transfusions. Other persons that often require platelet transfusions are patients undergoing extensive surgery, trauma or burn victims and individuals with platelet deficiencies such as caused by bone marrow disease.

..Currently, platelet storage time is limited to a maximum of five days as mandated by the FDA. Due to the fact that they are stored at room temperature creates potential bacterial problems and a loss of platelet functionality. Thousands of units of platelets are discarded at the end of the five-day period, creating shortages and waste that cost extraordinary amounts of money. Platelets older than three days may contain a high bacterial count causing a risk of infection to patients. In Japan the government requires that all platelets be used within three days.

..The FDA presently requires blood banks to perform tests to screen for viral diseases, which can take up two days. Currently bacterial testing has not been mandated due to the short period of time remaining for infusion. However, this situation may change because of consumer and government pressure to have blood centers and hospitals test for bacteria. If the FDA rules in favor of this proposed regulation it will undoubtedly cause many problems for the blood industry. The goal of HBS is to change this storage dilemma. With two issued patents and other pending, our unique technologies may double the storage period for platelets, dramatically reduce bacterial growth and maintain better platelet functionality. Upon further development and regulatory approvals, we expect to be a major supplier to the industry with our improved platelet storage technology.

Research: Slichter Lab Puget Sound Blood Services

..Platelet Transfusion Research
Background: Platelets are the blood cells involved in blood clotting. Platelets are prepared for transfusion by taking donated whole blood units and spinning them in a centrifuge. By using specific spinning conditions, the smaller, lighter platelets can be separated from the heavier red and white cells. Platelets are then stored in a small amount of residual plasma (the fluid part of the blood). Patients require the pooled platelets harvested from four to six units of donated blood to constitute an adequate transfusion dose to prevent or control bleeding in patients who have low platelet counts.

..Alternatively, enough platelets can be harvested from a single donor to give a transfusion dose by a procedure called apheresis. In an apheresis procedure, the donor’s blood is drawn from a blood vessel in one arm; this blood is passed through tubing into a spinning centrifuge bowl. The platelets are separated from the other blood components in the centrifuge. The separated platelets are automatically transferred to a collection bag and the other blood products are returned to the donor through a line placed in a vein in the opposite arm. This process is continued until enough platelets are collected from the donor for a transfusion dose. This apheresis procedure requires about one and a half to two hours of the donor’s time as opposed to collecting a unit of blood, which takes only about 20 minutes of the donor’s time.

..Because of the demand for platelets, both methods of preparing platelets are used in order to meet patient’s needs. The majority of platelets (about 60% - 70%) are given to patients with cancer. Either the chemotherapy or the stem cell transplant used to treat their cancer prevents the patient’s own bone marrow from making platelets. Often these patients require days to weeks of platelet transfusion therapy, until their own or the transplanted stem cells start making platelets. The majority of platelet transfusions given to cancer patients are given prophylactically to prevent bleeding.

..The next biggest use of platelets (30% - 40%) is given to trauma patients or open-heart surgery patients when platelet counts fall because of massive blood loss. These platelets are transfused therapeutically to help control their active bleeding until their vascular system is repaired.

..Opportunities for Improving Platelet Therapy
Our current research is focused in three major areas:
· To determine the appropriate dose of platelets to give cancer patients to prevent bleeding;
· To assess whether we can extend the storage time of platelets;
To develop techniques of preventing patients from recognizing donor platelets as foreign and rejecting them.

..Determining the Appropriate Dose of Prophylactic Platelets
The Puget Sound Blood Center is one of 17 trial sites across the U.S. that are part of the recently established Clinical Trials Network in Transfusion Medicine/Hemostasis funded by the National Institutes of Health. A prophylactic platelet dosage study in cancer patients, proposed by Dr. Slichter, has been selected as the first clinical trial to be initiated by the Network. In this study, cancer patients are randomly assigned to receive all their platelet transfusions at a low dose, a medium dose or a high dose. The goals of this trial are to evaluate bleeding risk based on transfused platelet dose and how many total platelets are transfused in each study group. The primary objective is to determine the lowest dose of platelets that prevents bleeding. Although enrollment in the study has started, it will probably be another two years before enrollment is completed and the results of the study have been analyzed.

..Extending the Storage Time of Platelets
As platelets can currently only be stored for five days, as opposed to the 42 days possible for red cells, the need to collect platelets drives the donor collection system. Dr. Slichter’s lab is actively pursuing techniques to extend the storage time of platelets. Using a physiologic solution instead of residual plasma to store the platelets, our preliminary data suggests that platelets may be stored for up to 13 days. These studies have been done by storing a normal donor’s own platelets, tagging their platelets with a radioactive substance after storage, and transfusing the donor with their radioactively labeled platelets. By drawing serial blood samples from the donor after transfusion, we can determine the recovery and survival of the donor’s stored platelets by measuring the residual amount of circulating platelet radioactivity.

..Future studies will involve transfusing the extended stored platelets into patients with low platelet counts to determine their ability to circulate and prevent or control bleeding.

..Preventing Transfused Donor Platelets from Being Rejected
Red blood cell transfusions usually require matching for only two blood group systems between donors and recipients (ABO & Rh) to prevent the rejection of donor red cells. Unfortunately, platelets require matching for the very complex histocompatibility system that must also be matched between organ donors and recipients (such as stem cell or kidney transplants) to prevent graft rejection. Platelets are transfused from random donors until the patient shows signs of rejecting these platelets as evidenced by no increase in the patient's post-tranfusion platelet count. If rejection of random platelets occurs, platelets must be obtained from histocompatible matched donors by apheresis procedures to obtain enough platelets to constitute a transfusion dose. The blood center maintains a registry of approximately 21,500 histocompatible typed donors to have a chance of finding one or more matched donors who will be able to provide compatible platelets for the genetically and racially diverse patient populations who require platelet transfusions. These platelet apheresis registry donors have agreed to be typed for histocompatibility markers and are on call to provide platelets for patients who are rejecting platelets from random donors.

..Using an animal model of transfusing platelets from random donors, Dr. Slichter’s lab has determined it is the white cells that contaminate the transfused platelets that signal the transfused recipients immune system that donor platelets are being transfused. These contaminating white cells activate the recipient’s immune system causing the rejection of the platelets from random donors. Unfortunately, the centrifugation procedures used to separate platelets from the other blood cells in a unit of whole blood or during an apheresis procedure does not completely remove all of the white cells. In our animal transfusion model, we have preliminary data to suggest that combining two different procedures may effectively prevent immune recognition of donor platelets. First is to remove a large number of white cells by using a filter designed to allow the platelets to pass through but not the white cells. If the filtered platelets are then gamma irradiated, this inactivates the residual white cells that the filter has not removed. Filtration and gamma irradiation procedures are both used routinely in blood centers. If we can show that combining these procedures is effective in preventing platelet rejection, these processes can easily be transferred to clinical application. However, additional animal studies are required to confirm these potentially very significant observations. Following the animal studies, transfusion studies in patients with low platelet counts will be used to determine the effectiveness of these approaches in patients.

· Platelet Dose: Once the minimal effective dose of prophylactic platelets that prevents bleeding is determined, this will be incorporated into patient care. We expect that the ongoing clinical trial will show that we can substantially reduce the number of platelets needed by cancer patients. This will not only decrease blood centers requirements to obtain donors for platelets but should, more importantly, substantially reduce patient care costs.
· Extend Platelet Storage Times: Having a longer shelf life for platelets will significantly reduce the current outdate rate for platelets as well as decrease our need for donors. It will also mean that we will be able to maintain a much larger inventory of platelets, thereby having a continuous supply of platelets readily available to meet patient needs.
· Preventing Platelet Rejection: Approximately 20% to 30% of chronically transfused cancer patients reject platelets from random donors. For these patients, it requires a substantial time commitment from platelet apheresis donors to support their platelet needs. For some patients, matched platelets are not available, which increases their bleeding risk. Therefore, preventing a transfused recipient’s immune system from recognizing donor platelets as foreign will be a significant benefit to both patients and platelet donors.

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