WO1996029864A1 - Methode de rajeunissement de globules rouges perimes - Google Patents

Methode de rajeunissement de globules rouges perimes Download PDF

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Publication number
WO1996029864A1
WO1996029864A1 PCT/US1996/003999 US9603999W WO9629864A1 WO 1996029864 A1 WO1996029864 A1 WO 1996029864A1 US 9603999 W US9603999 W US 9603999W WO 9629864 A1 WO9629864 A1 WO 9629864A1
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WO
WIPO (PCT)
Prior art keywords
solution
biologically compatible
blood cells
red blood
red
Prior art date
Application number
PCT/US1996/003999
Other languages
English (en)
Inventor
Harold T. Meryman
Original Assignee
Organ, Inc.
American National Red Cross
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Organ, Inc., American National Red Cross filed Critical Organ, Inc.
Priority to AU54293/96A priority Critical patent/AU5429396A/en
Publication of WO1996029864A1 publication Critical patent/WO1996029864A1/fr

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Classifications

    • 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
    • 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

Definitions

  • This invention relates to a method for rejuvenating stored red cells.
  • Red cells stored by refrigeration have a limited shelf-life depending on the solutions in which they are stored.
  • Cells collected in CPDA1 can be stored for 5 weeks without further treatment with or without removal of the plasma. More recent procedures involve the separation of red cells from the plasma and subsequent dilution of the cells with 100ml of an additive solution.
  • the three currently- licensed solutions are Adsol, Nutricel and Sagman. Cells stored with these additive solutions have a six-week shelf-life.
  • shelf-life is determined, in the United States at least, by measurements of the proportion of cells circulating in the recipient 24-hrs after transfusion.
  • the FDA has unofficially established 75% as the minimum for a licensed product.
  • the quantity of free hemoglobin that is transfused can also limit shelf-life. Although no official maximum has been established, there is general agreement that hemolysis should not exceed 1%.
  • ATP adenosine triphosphate
  • 2,3-diphosphoglycerate (2,3-DPG)
  • the concentration of ATP after a brief initial rise, progressively declines to between 30 and 40% of its initial level after six weeks of storage.
  • the fluidity of the cell membrane of red cells which is essential for the passage of red cells through the narrow channels in the spleen and liver, is loosely correlated with the level of ATP.
  • the primary function of red cells in the circulation is to deliver oxygen to the tissues.
  • a unique characteristic of hemoglobin is that it can unload much of its oxygen even though the partial pressure of oxygen in the tissues may be relatively high.
  • 2,3-diphosphoglycerate (2,3-DPG) is essential to this process and, in its absence, oxygen is not efficiently delivered to the tissues.
  • 2,3-DPG 2,3-diphosphoglycerate
  • the level of 2,3-DPG falls rapidly after about three or four days of storage and approaches zero by about ten days.
  • red cells that are transfused must be capable of remaining in circulation twenty-four hours following the transfusion.
  • concentration of ATP and the morphology of red cells serve as indicators of the suitability of stored cells for transfusion.
  • the invention provides a method for rejuvenating red blood cells designed not only to restore 2,3-DPG but also to improve twenty-four hour survival of the cells and to permit a prolonged period of post-rejuvenation storage.
  • This invention provides a method for rejuvenating red cells stored in a red cell storage solution comprising adding a biologically compatible solution to the red cell storage solution without breaking the sterile closed- system of the red cell storage solution; and mixing the resultant solution.
  • the method may further comprise separating the red cells from a supernatant by sedimentation and removal of an amount of the supernatant such that the volume of the final red cell storage solution is preferably substantially equivalent to the volume of the original red cell storage solution.
  • this invention provides a method for rejuvenating stored red cells comprising: (a) attaching a storage bag comprising stored red cells to a sterile transfer pack containing a biologically compatible storage solution using a sterile connection device without breaking said sterile closed system; (b) introducing said biologically compatible storage solution into said storage bag; (c) mixing a resultant solution; (d) separating the red cells from a supernatant by sedimentation; (e) transferring at least a portion of the supernatant to the sterile transfer pack; (f) sealing the sterile connection device; and (g) detaching the sterile transfer pack from the storage bag so that the storage bag remains sealed.
  • stored red blood cells or “stored red cells” refers to red blood cells that have been stored, for example under conventional methods of refrigeration known to those of ordinary skill in the art, for at least one week and include red cells that have been stored for more than six weeks.
  • red blood cells or “rejuvenated stored red cells” refers to red blood cells that can be further stored under refrigerated conditions with low hemolysis and with cell morphological index and levels of ATP and 2,3-DPG that are greater than the levels of morphological index, ATP and 2,3-DPG in cells that have been stored under refrigerated conditions for the same amount of time without being rejuvenated.
  • Red cell storage solution is any solution for storing red blood cells.
  • Red cell storage solutions include, but are not limited to those known in the art such as those listed in Tables 1 and 2, infra.
  • a "biologically compatible storage solution” is a transfusable solution in which red cells can be stored under refrigerated conditions and the red cells that are contacted therewith retain viability. Contacting includes any process in which the cells are in some manner exposed to the solution and includes, but is not limited to, suspension of the cells in the solution.
  • a biologically compatible storage solution has a pH and a salt concentration that are suitable for maintaining the integrity of the cell membrane and do not inhibit or destroy the biological and physiological reactions of the cells contacted therewith.
  • a biologically compatible storage solution typically has a pH between 6 and 9.5 and is isotonic or only moderately hypotonic or hypertonic.
  • Biologically compatible storage solutions include, but are not limited to known solutions such as those listed in Table 2, infra. TABLE 2
  • an effectively hypotonic solution is one in which the combined osmolality of solutes that do not penetrate the red cell membranes is less than the combined osmolality of the extracellular red cell storage solution.
  • Such solutions are known to one of ordinary skill in the art.
  • Refrigerated conditions refers to conditions for storing red blood cells under refrigeration. Refrigerated conditions include, but are not limited to, temperatures of 4 ⁇ 2°C.
  • red cells rejuvenated using this method may be subsequently stored for additional time before being transfused.
  • the red cells may be stored for more than 48 hours after the rejuvenation procedure and, preferably, they are stored for more than one week.
  • the rejuvenated cells may be transfused after being stored for more than four weeks and may be used even after subsequent storage for six weeks.
  • Figure 1 shows the mean and standard deviation for red cell morphology and percent hemolysis for six units of red cells that are filtered into collection bags and stored unmixed for six weeks at 4°C using Nutricel additive, rejuvenated using a solution containing 69 mM Glucose, 30.6 mM NaCitrate, 13.2 mM Na 2 HP0 4 and 2 mM Adenine, and stored for an additional six weeks at 4°C.
  • each unit is connected to a sterile transfer pack (Fenwal 4R2014) filled with approximately 370 ml of the solution; the solution is transferred into the collection bag until full; the bags are centrifuged at high speed for 8 minutes; the supernatant is transferred to the transfer pack until full; and the bags are disconnected.
  • a sterile transfer pack (Fenwal 4R2014) filled with approximately 370 ml of the solution; the solution is transferred into the collection bag until full; the bags are centrifuged at high speed for 8 minutes; the supernatant is transferred to the transfer pack until full; and the bags are disconnected.
  • Figure 1 demonstrates that when the rejuvenation procedure is applied after six weeks of storage, the morphology index of the red cells increases over the next week of refrigerated storage. Over the subsequent weeks, the morphology index slowly returns to where it was at six weeks. The values recorded during the twelve week period are indicative of clinical acceptability.
  • the biologically compatible solution comprises glucose, phosphate, adenine and citrate.
  • the solution is effectively hypotonic.
  • the solution has a higher pH than currently licensed red cell storage solutions; more preferably, the solution is selected to raise the intracellular pH of the red blood cells.
  • the pH of the solution preferably should be at least 7.
  • the method provides for adding the solution to red blood cells stored in a red cell storage solution without breaking the sterile closed system of the red cell storage solution and mixing the resultant solution.
  • the closed system is maintained so that the resulting solution can be stored under refrigerated conditions without risk of bacterial contamination or a need to discard the rejuvenated cells after only 24 hours to reduce that risk.
  • the solution may be added by attaching a storage bag comprising stored red cells to a sterile transfer pack containing the rejuvenating solution using a sterile connection device and introducing the solution into the storage bag through the sterile connection device.
  • a sterile transfer pack containing the rejuvenating solution
  • Haemonetics model SCD 312 may be used. It is often desirable to maintain the volume of the red cell storage solution in order to transfuse the red cells into a patient. Therefore, it may be necessary to remove excess solution from the red cells. Excess solution may be removed after the red cells have been separated from a supernatant by sedimentation. The sedimentation may occur by, for example, centrifugation. In particular, the assembly of the two bags may be placed in a centrifuge in an orientation that causes the red cells to sediment to the bottom of the storage bag. After sedimentation has occurred, an amount of supernatant may be removed such that the volume of the final red cell solution is substantially equivalent to the volume of the original red cell storage solution.
  • the sterile connection device may be temporarily sealed after the biologically compatible solution is transferred into the storage bag so that the solution cannot flow back into the sterile plastic transfer pack.
  • a removable clip can be attached to the sterile connection device.
  • the sedimentation of red cells can occur naturally or, much more preferably, for example, by placing the storage bag in a centrifuge to separate the red cells from the supernatant. After the separation is complete, the seal in the sterile connection device can be removed to allow supernatant to be transferred into the sterile plastic pack by, for example, a plasma press.
  • the pack is full of the biologically compatible solution.
  • the supernatant can be transferred to the sterile plastic transfer pack until it is again full, thereby maintaining a substantially equivalent volume in the storage bag to the volume present before the rejuvenation process.
  • the sterile plastic transfer pack can be calibrated so that the amount of solution in the pack before and after the rejuvenating process can be measured and adjusted as desired.
  • Standard blood storage bags have a capacity of approximately 600 milliliters, while the average volume of the stored cells which they contain is generally approximately 360 milliliters.
  • the volume of the rejuvenation solution bag exceeds the additional volume available in the red cell storage bag, therefore allowing the storage bag to be filled.
  • the subsequent storage of the red cells following rejuvenation will be improved if it is possible to introduce a larger volume of solution into the blood bag. This could also be achieved by repeating the process with a plurality of smaller bags of rejuvenation solution, but this approach is less preferred.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
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Abstract

Méthode de rajeunissement de globules rouges stockés dans une solution consistant à ajouter à ladite solution une solution à compatibilité biologique à l'intérieur d'un système fermé stérile, sans rupture dudit système, puis à mélanger la solution de globules rouges résultante.
PCT/US1996/003999 1995-03-24 1996-03-22 Methode de rajeunissement de globules rouges perimes WO1996029864A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU54293/96A AU5429396A (en) 1995-03-24 1996-03-22 Rejuvenating outdated red cells

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US40959895A 1995-03-24 1995-03-24
US08/409,598 1995-03-24

Publications (1)

Publication Number Publication Date
WO1996029864A1 true WO1996029864A1 (fr) 1996-10-03

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Application Number Title Priority Date Filing Date
PCT/US1996/003999 WO1996029864A1 (fr) 1995-03-24 1996-03-22 Methode de rajeunissement de globules rouges perimes

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AU (1) AU5429396A (fr)
WO (1) WO1996029864A1 (fr)

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1458235A1 (fr) * 2001-11-16 2004-09-22 Hemanext, LLC Solution d'additif pour la conservation de sang
US7723017B2 (en) * 2001-11-16 2010-05-25 The Trustees Of Boston University Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation
US8535421B2 (en) 2009-10-12 2013-09-17 New Health Sciences, Inc. Blood storage bag system and depletion devices with oxygen and carbon dioxide depletion capabilities
US8569052B2 (en) 2009-10-12 2013-10-29 New Health Sciences, Inc. Oxygen depletion devices and methods for removing oxygen from red blood cells
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
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
US9005343B2 (en) 2010-05-05 2015-04-14 New Health Sciences, Inc. Integrated leukocyte, oxygen and/or CO2 depletion, and plasma separation filter device
US9067004B2 (en) 2011-03-28 2015-06-30 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
WO2015171551A1 (fr) * 2014-05-05 2015-11-12 Biomet Manufacturing, Llc Filtre de séparation du sang
US9199016B2 (en) 2009-10-12 2015-12-01 New Health Sciences, Inc. System for extended storage of red blood cells and methods of use
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
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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4804363A (en) * 1986-07-16 1989-02-14 Autologous Blood Corporation Apparatus and method for storing and processing blood
US5250303A (en) * 1989-10-06 1993-10-05 The American National Red Cross Procedure for storing red cells with prolonged maintenance of cellular concentrations of ATP and 2,3 DPG

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4804363A (en) * 1986-07-16 1989-02-14 Autologous Blood Corporation Apparatus and method for storing and processing blood
US5250303A (en) * 1989-10-06 1993-10-05 The American National Red Cross Procedure for storing red cells with prolonged maintenance of cellular concentrations of ATP and 2,3 DPG

Cited By (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1458235A4 (fr) * 2001-11-16 2005-04-06 Hemanext Llc Solution d'additif pour la conservation de sang
US7723017B2 (en) * 2001-11-16 2010-05-25 The Trustees Of Boston University Method for extending the useful shelf-life of refrigerated red blood cells by nutrient supplementation
US8071282B2 (en) * 2001-11-16 2011-12-06 The Trustees Of Boston University Method of storing red blood cells with an acidic additive solution under oxygen depletion
EP1458235A1 (fr) * 2001-11-16 2004-09-22 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
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
US10603417B2 (en) 2009-10-12 2020-03-31 Hemanext Inc. System for extended storage of red blood cells and methods of use
US8535421B2 (en) 2009-10-12 2013-09-17 New Health Sciences, Inc. Blood storage bag system and depletion devices with oxygen and carbon dioxide depletion capabilities
US9844615B2 (en) 2009-10-12 2017-12-19 New Health Sciences, Inc. System for extended storage of red blood cells and methods of use
US9095662B2 (en) 2009-10-12 2015-08-04 New Health Sciences, Inc. Blood storage bag system and depletion devices with oxygen and carbon dioxide depletion capabilities
US8569052B2 (en) 2009-10-12 2013-10-29 New Health Sciences, Inc. Oxygen depletion devices and methods for removing oxygen from red blood cells
US9199016B2 (en) 2009-10-12 2015-12-01 New Health Sciences, Inc. System for extended storage of red blood cells and methods of use
US9296990B2 (en) 2009-10-12 2016-03-29 New Health Sciences, Inc. Oxygen depletion devices and methods for removing oxygen from red blood cells
US11864553B2 (en) 2009-10-23 2024-01-09 Fenwal, Inc. Methods and systems for providing red blood cell products with reduced plasma
US9409128B2 (en) 2009-10-23 2016-08-09 Fenwal, Inc. Methods for storing red blood cell products
US9943077B2 (en) 2009-10-23 2018-04-17 Fenwal, Inc. Methods for storing red blood cell products
US9539375B2 (en) 2010-05-05 2017-01-10 New Health Sciences, Inc. Integrated leukocyte, oxygen and/or CO2 depletion, and plasma separation filter device
US9005343B2 (en) 2010-05-05 2015-04-14 New Health Sciences, Inc. Integrated leukocyte, oxygen and/or CO2 depletion, and plasma separation filter device
US11284616B2 (en) 2010-05-05 2022-03-29 Hemanext Inc. Irradiation of red blood cells and anaerobic storage
US10065134B2 (en) 2010-05-05 2018-09-04 New Health Sciences, Inc. Integrated leukocyte, oxygen and/or CO2 depletion, and plasma separation filter device
US10136635B2 (en) 2010-05-05 2018-11-27 New Health Sciences, Inc. Irradiation of red blood cells and anaerobic storage
US9339025B2 (en) 2010-08-25 2016-05-17 New Health Sciences, Inc. Method for enhancing red blood cell quality and survival during storage
US10251387B2 (en) 2010-08-25 2019-04-09 New Health Sciences, Inc. Method for enhancing red blood cell quality and survival during storage
US9067004B2 (en) 2011-03-28 2015-06-30 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
US9968718B2 (en) 2011-03-28 2018-05-15 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
US9877476B2 (en) 2013-02-28 2018-01-30 New Health Sciences, Inc. Gas depletion and gas addition devices for blood treatment
US10687526B2 (en) 2013-02-28 2020-06-23 Hemanext Inc. Gas depletion and gas addition devices for blood treatment
WO2015171551A1 (fr) * 2014-05-05 2015-11-12 Biomet Manufacturing, Llc Filtre de séparation du sang
US10058091B2 (en) 2015-03-10 2018-08-28 New Health Sciences, Inc. Oxygen reduction disposable kits, devices and methods of use thereof
US11350626B2 (en) 2015-03-10 2022-06-07 Hemanext Inc. Oxygen reduction disposable kits, devices and methods of use thereof (ORDKit)
US11375709B2 (en) 2015-03-10 2022-07-05 Hemanext Inc. Oxygen reduction disposable kits, devices and methods of use thereof
US11638421B2 (en) 2015-03-10 2023-05-02 Hemanext Inc. Oxygen reduction disposable kits, devices and methods of use thereof
US10849824B2 (en) 2015-04-23 2020-12-01 Hemanext Inc. Anaerobic blood storage containers
US9801784B2 (en) 2015-04-23 2017-10-31 New Health Sciences, Inc. Anaerobic blood storage containers
US11013771B2 (en) 2015-05-18 2021-05-25 Hemanext Inc. Methods for the storage of whole blood, and compositions thereof
US10583192B2 (en) 2016-05-27 2020-03-10 New Health Sciences, Inc. Anaerobic blood storage and pathogen inactivation method
US11147876B2 (en) 2016-05-27 2021-10-19 Hemanext Inc. Anaerobic blood storage and pathogen inactivation method
US11911471B2 (en) 2016-05-27 2024-02-27 Hemanext Inc. Anaerobic blood storage and pathogen inactivation method

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Publication number Publication date
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