Method for enhancing red blood cell quality and survival during storage

• US 10,251,387 B2
• Filed: 04/11/2016
• Issued: 04/09/2019
• Est. Priority Date: 08/25/2010
• Status: Active Grant

• Current Assignee: The Trustees of Dartmounth College (Dartmouth College), Hemanext Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Dumont, Larry J., Yoshida, Tatsuro
• Primary Examiner(s): Landau, Sharmila G
• Assistant Examiner(s): McNeil, Stephanie A
• Application Number:
  US15/095,943
• Publication Number:
  US 20160219868A1
• Time in Patent Office: 1,093 Days
• CPC Class Codes: A01N 1/021 Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
• CPC Class Codes: A01N 1/0242 Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
• CPC Class Codes: A61M 1/0272 Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
• CPC Class Codes: C12N 5/0641 Erythrocytes

Abstract

The present invention is a method for enhancing the quality and survival of red blood cells during storage by depleting the red blood cells of both carbon dioxide and oxygen and maintaining 2,3-diphosphoglycerate acid levels.

Claims

1. A method for enhancing red blood cell quality and survival during storage comprising

depleting a red blood cell sample of leukocytes;

depleting said leukocyte depleted red blood sample of platelets;

adding an additive solution having a pH ranging from 5.5 to 7.0;

depleting said leukoreduced and platelet reduced red blood cell sample of both oxygen and carbon dioxide prior to storage, wherein carbon dioxide is depleted to a level of 5 mmHg at 21-25°

C.;

reducing pathogens in said red blood cell sample; and

transferring the leukocyte, platelet, pathogen and oxygen- and carbon dioxide-depleted red blood cell sample to an oxygen- and carbon dioxide-impermeable environment for storage, wherein said red blood cell sample has an acidic pH,

thereby enhancing red blood cell quality and survival during storage.

2. The method of claim 1, wherein 2,3-diphosphoglycerate (2,3-DPG) acid levels are maintained for at least two weeks.

3. The method of claim 1, wherein the red blood cell sample is stored for at least three weeks.

4. The method of claim 3, wherein the red blood cells exhibit less than 0.2% hemolysis.

5. The method of claim 1, wherein the red blood cells sample is stored for at least seven weeks.

6. The method of claim 5, wherein the red blood cells exhibit less than 0.3% hemolysis.

7. The method of claim 1, wherein the red blood cells sample is stored for at least nine weeks.

8. The method of claim 7, wherein the red blood cells exhibit less than 0.7% hemolysis.

9. The method of claim 1, wherein the red blood cell sample is depleted of oxygen to a level of approximately 10 mmHg at 21-25°

C.

10. The method of claim 1, wherein said additive solution has a pH ranging from 6.25 to 6.75.

11. The method of claim 1, wherein the oxygen- and carbon dioxide-impermeable environment for storage is between 1°

C. and 6°

C.

12. The method of claim 1, wherein the red blood cell sample is selected from the group consisting of whole blood, anti-coagulated whole blood, packed red cells and red cells separated from plasma.

13. A method for enhancing red blood cell quality and survival during storage comprising

(a) reducing oxygen and carbon dioxide in a red blood cell sample comprising an acidified additive solution prior to storage;

(b) reducing pathogens; and

(c) storing the oxygen and carbon dioxide reduced red blood cell sample in an oxygen and carbon dioxide-impermeable storage environment, wherein said red blood cell sample has an acidic pH,

wherein adenosine triphosphate (ATP) and 2,3-diphosphoglycerate (2,3-DPG) levels are optimized during storage in the oxygen- and carbon dioxide-impermeable storage environment.

14. The method of claim 13, wherein the red blood cell sample is depleted of oxygen to a level of approximately 10 mmHg at 21-25°

C.

15. The method of claim 13, wherein the red blood cell sample is depleted of carbon dioxide to a level of 5 mmHg at 21-25°

C.

16. The method of claim 13, wherein reducing carbon dioxide in the red blood cell sample elevated 2,3-DPG levels relative to a red blood cell sample in which carbon dioxide was not depleted.

17. The method of claim 13, wherein reducing carbon dioxide and oxygen in the red blood cell sample maintains ATP levels higher for a nine week period than ATP levels in a red blood cell sample in which neither oxygen nor carbon dioxide are depleted and maintains 2,3-DPG levels higher for three weeks than 2,3-DPG levels in a red blood cell sample in which neither oxygen nor carbon dioxide are depleted.