US20030153074A1 - Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation - Google Patents
Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation Download PDFInfo
- Publication number
- US20030153074A1 US20030153074A1 US10/295,772 US29577202A US2003153074A1 US 20030153074 A1 US20030153074 A1 US 20030153074A1 US 29577202 A US29577202 A US 29577202A US 2003153074 A1 US2003153074 A1 US 2003153074A1
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- Prior art keywords
- red blood
- blood cells
- oxygen
- metabolic
- refrigerated
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
- A01N1/0226—Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Definitions
- the present invention relates to the preservation of blood in liquid form. More particularly, the present invention relates to enhancement of the shelf-life of oxygen-depleted refrigerated storage of red blood cells. Still more particularly, compositions and methodology involving nutrient or metabolic supplementation of red blood cells stored in liquid form in oxygen-depleted refrigeration are provided.
- This invention was made with partial support by the United States Office of Naval Research, Contract No. N00014-98-1-0451. The Government has certain rights in the invention.
- Red blood cells may, for example, be stored under refrigeration at a temperature above freezing (4° C.) as packed blood cell preparations. Red blood cells may be concentrated from whole blood with separation of the liquid blood component (plasma). Expired blood cannot be used and is discarded. There are periodic shortages of blood that occur due to donation fluctuation, emergencies and other factors. The logistics of blood supply and distribution impact the military, especially during times of combat, and remote hospitals or medical facilities. There is currently a need for the storage of autologous blood to avoid the significant risks of infection associated with non-autologous donor blood. Patients currently cannot collect and store with current technology enough autologous blood for certain pre-planned surgeries, including hip replacement, organ transplantation and the like.
- frozen blood has limitations. For a number of years, frozen blood has been used by blood banks and the military for certain high-demand and rare types of blood. However, frozen blood is difficult to handle. It must be thawed which makes it impractical for emergency situations. Once blood is thawed, it must be used within 24 hours.
- U.S. Pat. No. 4,769,318 to Hamasaki et al. is directed to additive solutions for blood preservation and activation.
- U.S. Pat. No. 5,624,794 to Bitensky et al. and also U.S. Pat. No. 6,162,396 to Bitensky et al. are directed to the storage of red blood cells under oxygen-depleted conditions.
- U.S. Pat. No. 5,789,151 to Bitensky et al. is directed to blood storage additive solutions.
- Rejuvesol available from enCyte Corp., Braintree, Mass.
- Rejuvesol is add to blood after cold storage (i.e., 4° C.) just prior to transfusion or prior to freezing (i.e., at ⁇ 80° C. with glycerol) for extended storage.
- Another object of the present invention to provide a method for extending the storage of red blood cells using oxygen-free additive solutions and oxygen removal.
- the present invention provides methods and compositions for extending the useful shelf-life of red blood cells.
- the method of the invention comprises adding a metabolic supplement to packed red blood cells, adding an additive solution, preferably an oxygen-free additive solution, to said red blood cells, and storing said red blood cells at a temperature above freezing, preferably 4° C., under conditions of oxygen-depletion.
- Metabolic supplement compositions of the invention comprise pyruvate, inosine, adenine, monobasic and dibasic phosphate salts at a pH from about 5 to about 8. Rejuvesol, or modification thereof, may be used as a metabolic supplement solution.
- Oxygen depletion may be effected by flushing the red blood cells with an inert gas as described with oxygen depleted refrigerated storage in U.S. Pat. No. 5,624,794 and U.S. Pat. No. 6,162,396.
- Preferred oxygen-free additive solutions comprise modifications of EAS61 (Hess et al., Transfusion 40: 1007-1011), and OFAS1 (U.S. Pat. No. 5,789,151).
- a preferred oxygen-free additive solution is OFAS3.
- the present invention extends the useful shelf life of refrigerated packed red blood cells from the current approximately 6 week limit to about 12 to about 20 weeks.
- FIG. 1 shows the effect of pH and oxygen depletion on cellular ATP levels of red blood cells in OFAS3.
- FIG. 2 shows the effect of pH and oxygen depletion on the percentage of red blood cells exposing phosphotidylserine in OFAS3.
- FIG. 3 shows the effect of pH and oxygen depletion on red blood cell hemolysis in OFAS3.
- FIG. 4 shows the effect on red blood cell ATP levels of metabolic supplements added at different pH's in the presence or absence of oxygen.
- FIG. 5 shows the effect on red blood cell 2,3-DPG levels of metabolic supplements added at different pH's in the presence or absence of oxygen.
- FIG. 6 shows the effect on the percentage of red blood cells exposing phosphotidylserine of addition of metabolic supplements at different pH's in the presence and absence of oxygen.
- FIG. 7 shows the effect on vesicle protein production of red blood cells of addition of metabolic supplements at different pH's in the presence or absence of oxygen.
- the present invention provides methods and compositions extending the useful shelf life of refrigerated red blood cells.
- the present invention more than doubles the useful shelf life of red blood cells and overcomes current limitations in the blood industry by providing longer and less perishable blood supplies.
- Metabolic supplementation is used commercially.
- Rejuvesol is indicated for use at 37° C. and a 1 hour rejuvenation of stored blood just prior to transfusion or just prior to freezing in glycerol.
- the present invention describes addition of metabolic supplement during refrigerated storage combined with the use of oxygen free additive solution (i.e., OFAS3) and oxygen removal.
- OFAS3 oxygen free additive solution
- unprecedented results have been obtained. For example, red blood cell storage well beyond the current 6-week limit for 12 or up to 20 weeks at 4° C. with levels of 2-3 DPG and ATP that are above those found in freshly drawn blood.
- Metabolic supplementation of the invention is effected at least once, preferably during oxygen-depleted refrigerated storage (i.e., 4°) of red blood cells (c.f., U.S. Pat. Nos. 5,624,794; 6,162,396), along with oxygen-free additive solution, preferably OFAS3 or modification thereof. Blood units are not warmed. EAS61 and OFAS1 are additive solutions known in the art.
- Metabolic supplement is added to refrigerated red blood cells. A first addition is made within 6-10 weeks of storage. A second addition is optionally added within 11-20 weeks of storage.
- Metabolic supplement solution composition is presented in Table 1.
- Table 1 Concentration Ingredient (g/unit of addition) Na pyruvate 0.1-2.0 Inosine 0.5-3.0 Adenine 0.01-1.0 Na phosphate dibasic 0-2.0 Na phosphate monobasic 0-2.0 pH 5.5-8.0
- test units were stored in an anaerobic environment following multiple flushes to minimize the oxygen content of each unit using highly purified Ar and H 2 Following completion of sampling, the test units were made anaerobic following the procedure provided by the sponsor. Briefly, the units were transferred to a 2000 mL transfer bag using the SCD. Sputtering grade argon was introduced into the unit via a 0.22 micron filter until the transfer bag was completely filled with gas/blood and rotated 10 min at room temperature. Following this hold period, the gas was expelled through the same 0.22 micron filter using a plasma expressor and a vacuum line. This procedure was repeated 6 times, and the unit was transferred to a standard PL146 red cell storage bag with an Ar flush.
- the unit was then placed in an anaerobic culture jar and 3 exchanges of the contents of the jar were performed with Ar, the last consisting of 2 parts Ar, 1 part scientific grade H 2 before the jar was placed in a monitored 4° C. refrigerator.
- the storage jar again underwent gas replacement prior to the unit being placed back in the refrigerator.
- Jars were flushed weekly with Ar if no sampling occurred in that week. Control units were stored in the same refrigerator without altering their gaseous environment.
- test units After 7 weeks of storage, test units underwent a metabolic supplementation using a licensed solution (Rejuvesol, Cytosol Laboratories, Braintree, Mass.); test units underwent an additional metabolic supplementation at 11 weeks (if recoveries to date indicated that continued storage was warranted, vida infra)
- the contents of the bottle of metabolic supplement were aspirated via needle and syringe and injected via a sampling port into a plastic transfer bag that had been previously flushed with Ar and to which had already been attached a 0.22 micron filter.
- the solution was then transferred to the unit by sterile docking, and the unit was promptly returned to refrigerated storage (without repeating the gas exchange procedure and without incubation or washing).
- Control units were utilized for radiolabeling and autologous reinfusion at 10 weeks; test units were continued in the protocol so long as the prior radiolabeled recovery suggested the continued viability of the cells.
- the ATP must have been at least 50% of the Day 0 value, and the hemolysis must have been no more than 3.0% at the preceding sampling.
- Radiolabe]ing to allow for determination or in vivo red cell recovery was conducted according to published procedures [J. Nucl. Med. 1975; 16:435-7] 10-20 ⁇ CiNa 2 51 CrO 4 (Bracco, Princeton, N.J.) were added to a 10 mL aliquot of the unit's cells for 30 min. at room temperature followed by a single double-volume saline wash.
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- Chemical Kinetics & Catalysis (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/295,772 US20030153074A1 (en) | 2001-11-16 | 2002-11-15 | Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation |
US11/138,135 US7723017B2 (en) | 2001-11-16 | 2005-05-26 | Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US33240901P | 2001-11-16 | 2001-11-16 | |
US10/295,772 US20030153074A1 (en) | 2001-11-16 | 2002-11-15 | Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/138,135 Continuation US7723017B2 (en) | 2001-11-16 | 2005-05-26 | Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation |
Publications (1)
Publication Number | Publication Date |
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US20030153074A1 true US20030153074A1 (en) | 2003-08-14 |
Family
ID=23298102
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/295,772 Abandoned US20030153074A1 (en) | 2001-11-16 | 2002-11-15 | Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation |
US11/138,135 Expired - Lifetime US7723017B2 (en) | 2001-11-16 | 2005-05-26 | Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/138,135 Expired - Lifetime US7723017B2 (en) | 2001-11-16 | 2005-05-26 | Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation |
Country Status (6)
Country | Link |
---|---|
US (2) | US20030153074A1 (fr) |
EP (1) | EP1450604A4 (fr) |
JP (1) | JP2005535279A (fr) |
AU (1) | AU2002366082A1 (fr) |
CA (1) | CA2467223A1 (fr) |
WO (1) | WO2003043571A2 (fr) |
Cited By (17)
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---|---|---|---|---|
US20060086675A1 (en) * | 2004-10-22 | 2006-04-27 | Cryofacets, Inc. | System, chamber, and method for fractionation and elutriation of fluids containing particulate components |
US20060147895A1 (en) * | 2004-10-22 | 2006-07-06 | Cryofacets, Inc. | System, chamber, and method for fractionation, elutriation, and decontamination of fluids containing cellular components |
US20090239208A1 (en) * | 2008-03-21 | 2009-09-24 | Veronique Mayaudon | Red Blood Cell Storage Medium For Extended Storage |
US20110117647A1 (en) * | 2008-03-21 | 2011-05-19 | Fenwal, Inc. | Red Blood Cell Storage Medium For Extended Storage |
US9005343B2 (en) | 2010-05-05 | 2015-04-14 | New Health Sciences, Inc. | Integrated leukocyte, oxygen and/or CO2 depletion, and plasma separation filter device |
US20150147744A1 (en) * | 2011-03-28 | 2015-05-28 | New Health Sciences, Inc. | Method and system for removing oxygen and carbon dioxide during red cell blood processing using an inert carrier gas and manifold assembly |
US9315775B2 (en) | 2011-03-16 | 2016-04-19 | Mayo Foundation For Medical Education And Research | Methods and materials for prolonging useful storage of red blood cell preparations and platelet preparations |
US9339025B2 (en) | 2010-08-25 | 2016-05-17 | New Health Sciences, Inc. | Method for enhancing red blood cell quality and survival during storage |
US9409128B2 (en) | 2009-10-23 | 2016-08-09 | Fenwal, Inc. | Methods for storing red blood cell products |
US9801784B2 (en) | 2015-04-23 | 2017-10-31 | New Health Sciences, Inc. | Anaerobic blood storage containers |
US9844615B2 (en) | 2009-10-12 | 2017-12-19 | New Health Sciences, Inc. | System for extended storage of red blood cells and methods of use |
US9877476B2 (en) | 2013-02-28 | 2018-01-30 | New Health Sciences, Inc. | Gas depletion and gas addition devices for blood treatment |
US10058091B2 (en) | 2015-03-10 | 2018-08-28 | New Health Sciences, Inc. | Oxygen reduction disposable kits, devices and methods of use thereof |
US10136635B2 (en) | 2010-05-05 | 2018-11-27 | New Health Sciences, Inc. | Irradiation of red blood cells and anaerobic storage |
US10583192B2 (en) | 2016-05-27 | 2020-03-10 | New Health Sciences, Inc. | Anaerobic blood storage and pathogen inactivation method |
US11013771B2 (en) | 2015-05-18 | 2021-05-25 | Hemanext Inc. | Methods for the storage of whole blood, and compositions thereof |
US11284616B2 (en) | 2010-05-05 | 2022-03-29 | Hemanext Inc. | Irradiation of red blood cells and anaerobic storage |
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CA2467087A1 (fr) * | 2001-11-16 | 2003-05-30 | Hemanext, Llc | Solution d'additif pour la conservation de sang |
US8828226B2 (en) | 2003-03-01 | 2014-09-09 | The Trustees Of Boston University | System for assessing the efficacy of stored red blood cells using microvascular networks |
US20050074743A1 (en) * | 2003-10-06 | 2005-04-07 | Purmal Andrei A. | Method and composition for treating a biological sample |
US9314014B2 (en) | 2004-02-18 | 2016-04-19 | University Of Maryland, Baltimore | Compositions and methods for the storage of red blood cells |
EP2271209B1 (fr) | 2008-03-27 | 2016-07-13 | Biolife Solutions, Inc. | Matériaux et procédés pour le prélévement hypothermique de sang total |
BR112012008683B8 (pt) | 2009-10-12 | 2022-11-08 | Hemanext Inc | dispositivo de armazenagem de sangue para armazenar sangue depletado de oxigênio e dióxido de carbono, dispositivo de depleção de oxigênio e dióxido de carbono, método para remover oxigênio e dióxido de carbono de hemácias, sistema de armazenagem de sangue, dispositivo de armazenagem de sangue, método para remover oxigênio de hemácias e método para aumentar os níveis de adenosina trifosfato (atp) nas hemácias |
WO2011046963A1 (fr) | 2009-10-12 | 2011-04-21 | New Health Sciences, Inc. | Dispositifs d'appauvrissement en oxygène et procédés pour retirer l'oxygène de globules rouges |
WO2011083490A2 (fr) * | 2009-12-31 | 2011-07-14 | Intas Pharmaceuticals Limited | Composition vétérinaire stable permettant une absorption améliorée du phosphore |
WO2011103179A1 (fr) * | 2010-02-16 | 2011-08-25 | Viacell, Llc | Compositions contenant de l'arginine et procédés de traitement des globules rouges |
US9066909B2 (en) | 2012-09-06 | 2015-06-30 | Biomet Biologics, Llc | Methods for producing and using rejuvenated red blood cells |
US10253295B2 (en) | 2012-09-06 | 2019-04-09 | Biomet Manufacturing, Llc | Methods for producing rejuvenated red blood cells |
US9011408B2 (en) | 2013-01-31 | 2015-04-21 | Biomet Biologics, Llc | Functionally-closed, sterile blood processing solution system and method |
US9102918B2 (en) | 2013-01-31 | 2015-08-11 | Biomet Biologics, Llc | Methods for rejuvenating red blood cells |
US9103842B2 (en) | 2013-01-31 | 2015-08-11 | Biomet Biologics, Llc | Methods for rejuvenating red blood cells |
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2002
- 2002-11-15 CA CA002467223A patent/CA2467223A1/fr not_active Abandoned
- 2002-11-15 JP JP2003545252A patent/JP2005535279A/ja active Pending
- 2002-11-15 US US10/295,772 patent/US20030153074A1/en not_active Abandoned
- 2002-11-15 EP EP02803633A patent/EP1450604A4/fr not_active Withdrawn
- 2002-11-15 WO PCT/US2002/036735 patent/WO2003043571A2/fr not_active Application Discontinuation
- 2002-11-15 AU AU2002366082A patent/AU2002366082A1/en not_active Abandoned
-
2005
- 2005-05-26 US US11/138,135 patent/US7723017B2/en not_active Expired - Lifetime
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Cited By (37)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20060086675A1 (en) * | 2004-10-22 | 2006-04-27 | Cryofacets, Inc. | System, chamber, and method for fractionation and elutriation of fluids containing particulate components |
US20060147895A1 (en) * | 2004-10-22 | 2006-07-06 | Cryofacets, Inc. | System, chamber, and method for fractionation, elutriation, and decontamination of fluids containing cellular components |
WO2007106666A2 (fr) * | 2006-03-01 | 2007-09-20 | Cryofacets, Inc. | SYSTÈME, CHAMBRE, ET PROCÉDÉ de fractionnement, d'ELUTRIATION, et de décontamination de fluides contenant deS composants cellulaires |
WO2007106666A3 (fr) * | 2006-03-01 | 2007-12-06 | Cryofacets Inc | SYSTÈME, CHAMBRE, ET PROCÉDÉ de fractionnement, d'ELUTRIATION, et de décontamination de fluides contenant deS composants cellulaires |
US20090239208A1 (en) * | 2008-03-21 | 2009-09-24 | Veronique Mayaudon | Red Blood Cell Storage Medium For Extended Storage |
US20110117647A1 (en) * | 2008-03-21 | 2011-05-19 | Fenwal, Inc. | Red Blood Cell Storage Medium For Extended Storage |
US8871434B2 (en) | 2008-03-21 | 2014-10-28 | Fenwal, Inc. | Red blood cell storage medium for extended storage |
US8968992B2 (en) | 2008-03-21 | 2015-03-03 | Fenwal, Inc. | Red blood cell storage medium for extended storage |
US11433164B2 (en) | 2009-10-12 | 2022-09-06 | Hemanext Inc. | System for extended storage of red blood cells and methods of use |
US9844615B2 (en) | 2009-10-12 | 2017-12-19 | New Health Sciences, Inc. | System for extended storage of red blood cells and methods of use |
US10603417B2 (en) | 2009-10-12 | 2020-03-31 | Hemanext Inc. | System for extended storage of red blood cells and methods of use |
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WO2003043571A3 (fr) | 2004-03-18 |
US20050277108A1 (en) | 2005-12-15 |
US7723017B2 (en) | 2010-05-25 |
AU2002366082A8 (en) | 2003-06-10 |
EP1450604A2 (fr) | 2004-09-01 |
CA2467223A1 (fr) | 2003-05-30 |
AU2002366082A1 (en) | 2003-06-10 |
EP1450604A4 (fr) | 2005-01-12 |
JP2005535279A (ja) | 2005-11-24 |
WO2003043571A2 (fr) | 2003-05-30 |
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