Compartmented cryopreservation container and uses thereof

Patent metadata

Field	Value
Publication number	US-11261423-B2
Application number	US-201816133157-A
Country	US
Kind code	B2
Filing date	Sep 17, 2018
Priority date	Feb 5, 2014
Publication date	Mar 1, 2022
Grant date	Mar 1, 2022

Abstract

Described are medical products, methods, and cryogenic bags or other containers suitable for storing and/or transporting and/or processing cellular compositions and other related materials. In certain aspects, the contents of such cryogenic bags may be warmed, mixed, and applied to a patient. Medical products described herein find particular use in treating diseased and/or damaged tissue such as in wound repair and/or bone repair. Related methods of manufacture are also described.

First claim

What is claimed is:

1. A method for preparing a cellularized matrix composition, comprising:
providing a cryogenically stored product including a cryogenic storage container defining a sealed internal volume, a cellular composition received in the sealed internal volume, and a porous matrix material in particulate form received in the sealed internal volume, wherein the porous matrix material in particulate form and the cellular composition are discrete from one another in the sealed internal volume;
thawing the cryogenically stored product;
after the thawing, mixing the porous matrix material in particulate form and the cellular composition while maintaining intact the sealed internal volume of the cryogenic storage container, so as to prepare a cellularized matrix composition within the sealed internal volume of the cryogenic storage container, wherein said mixing includes kneading the porous matrix material and cellular composition by exerting pressure on at least one flexible wall of the cryogenic storage container;
cutting a portion of the cryogenic storage container to create an opening to the internal volume to provide access to the cellularized matrix composition; and
removing the cellularized matrix composition from the cryogenic storage container through the opening.

2. The method for preparing a cellularized matrix composition of claim 1 , wherein said cellular composition includes an aqueous medium.

3. The method for preparing a cellularized matrix composition of claim 1 , wherein the cellularized matrix composition has a weight ratio of liquid to total solids of about 3:1 to about 7:1.

4. The method for preparing a cellularized matrix composition of claim 3 , wherein the cellularized matrix composition is a putty.

5. The method for preparing a cellularized matrix composition of claim 4 , wherein said cryogenically stored product further includes an aqueous carrier received in a sealed internal volume discrete from said cellular composition and said porous matrix material, and wherein said mixing includes mixing said aqueous carrier, said cellular composition, and said porous matrix material.

6. The method for preparing a cellularized matrix composition of claim 1 , wherein the porous matrix material comprises a particulate ECM tissue material.

7. The method for preparing a cellularized matrix composition of claim 6 , wherein the particulate ECM tissue material comprises collagen.

8. The method for preparing a cellularized matrix composition of claim 6 , wherein the particulate ECM tissue material includes one or more bioactive factors.

9. The method for preparing a cellularized matrix composition of claim 8 , wherein the one or more bioactive factors comprises heparin, heparin sulfate, hyaluronic acid, fibronectin, or cytokines.

10. The method for preparing a cellularized matrix composition of claim 6 , wherein the particulate ECM tissue material further comprises a sugar.

11. The method for preparing a cellularized matrix composition of claim 1 , wherein the cellular composition comprises stem cells.

12. The method for preparing a cellularized matrix composition of claim 11 , wherein the cellular composition comprises human stem cells.

13. The method for preparing a cellularized matrix composition of claim 1 , also comprising:
transferring the cellular composition from a first compartment to a mixing compartment within the sealed internal volume; and
transferring the porous matrix material from a second compartment to the mixing compartment within the sealed internal volume; and
wherein said mixing is conducted with the cellular composition and the porous matrix material in the mixing compartment.

14. The method for preparing a cellularized matrix composition of claim 13 , also comprising:
prior to said transferring the cellular composition, removing a seal between the first compartment and the mixing compartment; and
prior to said transferring the porous matrix material, removing a seal between the second compartment and the mixing compartment.

15. The method for preparing a cellularized matrix composition of claim 13 , wherein said transferring the cellular composition and said transferring the porous matrix material comprise inverting the cryogenic storage container to allow gravity drain of the cellular composition and the porous matrix material into the mixing compartment.

16. The method for preparing a cellularized matrix composition of claim 15 , wherein the cellularized matrix composition is a putty.

17. The method for preparing a cellularized matrix composition of claim 1 , wherein the cryogenically stored product includes the cellular composition received in a first compartment of the cryogenic storage container and the porous matrix material received in a second compartment of the cryogenic storage container, and wherein the first compartment and the second compartment are formed integrally with the cryogenic storage container by welded or fused wall portions of the cryogenic storage container.

18. The method for preparing a cellularized matrix composition of claim 13 , wherein the mixing compartment has at least one flexible wall, and wherein said mixing includes manipulating the at least one flexible wall so as to mix the cellular composition and the porous matrix material in the mixing compartment.

19. The method for preparing a cellularized matrix composition of claim 18 , wherein the cryogenically stored product further includes an aqueous carrier discrete from said cellular composition and said porous matrix material in the sealed internal volume, and wherein said mixing includes mixing said aqueous carrier, said cellular composition, and said porous matrix material in the mixing compartment.

20. The method of preparing a cellularized matrix composition of claim 19 , wherein the cellularized matrix composition is a putty.

Assignees

• Muffin Inc

Inventors

• Fearnot Neal E

Classifications

• A01N1/146

  Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving · CPC title

• A01N1/128 Primary

  Chemically defined matrices for immobilising, holding or storing living parts, e.g. alginate gels; Chemically altering living parts, e.g. by cross-linking · CPC title

• B01L2300/069

  Absorbents; Gels to retain a fluid · CPC title

• C12N5/0602 Primary

  Vertebrate cells · CPC title

• B01L7/50

  Cryostats · CPC title