Immunocompatible amniotic membrane products

Patent metadata

Field	Value
Publication number	US-11207353-B2
Application number	US-201916296475-A
Country	US
Kind code	B2
Filing date	Mar 8, 2019
Priority date	Feb 18, 2010
Publication date	Dec 28, 2021
Grant date	Dec 28, 2021

Abstract

Provided herein is a placental product comprising an immunocompatible amniotic membrane. Such placental products can be cryopreserved and contain viable therapeutic cells after thawing. The placental product of the present invention is useful in treating a patient with a tissue injury (e.g. wound or burn) by applying the placental product to the injury. Similar application is useful with ligament and tendon repair and for engraftment procedures such as bone engraftment.

First claim

The invention claimed is:

1. A cryopreserved amniotic membrane comprising cells native to the amniotic membrane; wherein at least 70% of the cells native to the amniotic membrane are viable;
wherein the cryopreserved amniotic membrane is immunocompatible; wherein the viable cells comprise two or more cell types selected from MSCs, fibroblasts, and epithelial cells; and wherein the cryopreserved amniotic membrane produces a non-immunogenic response in a mixed lymphocyte reaction assay.

2. The cryopreserved amniotic membrane of claim 1 , wherein the cryopreserved amniotic membrane generates less than about 50 pg/ml of IL-2αR in a mixed lymphocyte reaction assay.

3. The cryopreserved amniotic membrane of claim 1 , wherein the cryopreserved amniotic membrane generates less than about 20 pg/ml of IL-2αR in a mixed lymphocyte reaction assay.

4. The cryopreserved amniotic membrane of claim 1 , wherein the membrane is immunocompatible by being selectively depleted in one or more types of functional immunogenic cells.

5. The cryopreserved amniotic membrane of claim 1 , wherein the amniotic membrane produces a non-immunogenic response in an assay measuring the level of TNF-α release after lipopolysaccharide (LPS) stimulation.

6. The cryopreserved amniotic membrane of claim 5 , wherein the amniotic membrane produces a level of TNF-α release after LPS stimulation that is less than 420 pg/ml.

7. The cryopreserved amniotic membrane of claim 5 , wherein the amniotic membrane produces a level of TNF-α release after LPS stimulation that is less than 200 pg/ml.

8. The cryopreserved amniotic membrane of claim 1 , wherein the amniotic membrane is immunocompatible by being substantially free of immunogenic maternal cells.

9. The cryopreserved amniotic membrane of claim 8 , wherein the immunogenic maternal cells are maternal decidual cells, maternal leukocytes, or both.

10. The cryopreserved amniotic membrane of claim 1 , wherein the viable cells further comprise stromal cells.

11. The cryopreserved amniotic membrane of claim 10 , wherein the stromal cells are present at about 2,000 to about 15,000 cells per cm 2 of the amniotic membrane.

12. The cryopreserved amniotic membrane of claim 1 , further comprising at least one cell-permeating cryopreservative or a derivative thereof, at least one non-cell permeating cryopreservative or a derivative thereof, or a combination thereof.

13. The cryopreserved amniotic membrane of claim 12 , wherein the cell-permeating cryopreservative or derivative thereof or the non-cell-permeating cryopreservative or derivative thereof is present in an amount of about 5% to about 20% by volume.

14. The cryopreserved amniotic membrane of claim 13 , wherein the cell-permeating cryopreservative comprises DMSO.

15. The cryopreserved amniotic membrane of claim 1 , wherein the cryopreserved amniotic membrane comprises MSCs, wherein at least 40% of the MSCs are viable after a freeze-thaw cycle.

Assignees

• Osiris Therapeutics Inc

Inventors

• Tom Samson
• Danilkovitch Alla
• Yoo Dana
• Jansen Timothy
• Kuang Jin-Qiang
• Marconi Jennifer Michelle

Classifications

• A01N1/125 Primary

  Freeze protecting agents, e.g. cryoprotectants or osmolarity regulators · CPC title

• A61K38/57

  from animals; from humans {(A61K38/553, A61K38/556 take precedence)} · CPC title

• A61K35/50

  Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells · CPC title

• A61K38/1825

  Fibroblast growth factor [FGF] · CPC title

• A61K38/1841

  Transforming growth factor [TGF] · CPC title