Methods of manufacture of immunocompatible chorionic membrane products

Patent metadata

Field	Value
Publication number	US-12109241-B2
Application number	US-202318094148-A
Country	US
Kind code	B2
Filing date	Jan 6, 2023
Priority date	Feb 18, 2010
Publication date	Oct 8, 2024
Grant date	Oct 8, 2024

Abstract

Provided herein is a placental product comprising an immunocompatible chorionic 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 method of treating a skin and/or dermal tissue injury of a subject, the method comprising administering to the skin and/or dermal tissue injury of the subject a cryopreserved portion of a placenta,
wherein the cryopreserved placental portion comprises at least 70% viable therapeutic cells native to the placental portion,
wherein the cryopreserved placental portion is substantially depleted of immunogenic cells comprising trophoblasts, functional CD14+ macrophages, or both trophoblasts and functional CD14+ macrophages, and
wherein the cryopreserved placental portion comprises a chorionic membrane of the placenta or the cryopreserved placental portion has a thickness of about 40 μm to about 400 μm.

2. The method of claim 1 , wherein the cryopreserved placental portion is depleted of substantially all vascularized tissue or vascularized tissue-derived immunogenic cells.

3. The method of claim 1 , wherein the cryopreserved placental portion comprises a chorionic membrane of the placenta.

4. The method of claim 1 , wherein the cryopreserved placental portion does not comprise an amniotic membrane of the placenta.

5. The method of claim 1 , wherein the cryopreserved placental portion comprises at least 15.9% of amniotic epithelial cells.

6. The method of claim 1 , wherein the cryopreserved placental portion comprises at least 80% viable therapeutic cells native to the placental portion.

7. The method of claim 1 , wherein the viable native therapeutic cells comprise mesenchymal stem cells and fibroblasts.

8. The method of claim 1 , wherein the viable native therapeutic cells express CD105, CD166, C90, CD73, CD49, or a combination thereof.

9. The method of claim 1 , wherein the cryopreserved placental portion comprises therapeutic factors native to the placental portion, and wherein the therapeutic factors comprise IGFBP1, adiponectin, α2-macroglobulin, bFGF, EGF, MMP-9, TIMP1, or a combination thereof.

10. The method of claim 1 , wherein the cryopreserved placental portion has a thickness of about 40 μm to about 400 μm.

11. The method of claim 1 , wherein the cryopreserved placental portion has 20,000 to about 200,000 cells per cm 2 .

12. The method of claim 1 , wherein the tissue injury is a wound.

13. The method of claim 12 , wherein the tissue injury is an epidermal wound, skin wound, chronic wound, acute wound, external wound, internal wounds, congenital wound, ulcer, or pressure ulcer.

14. The method of claim 1 , wherein the tissue injury is a burn.

15. The method of claim 14 , wherein the tissue injury is a first-degree burn, second-degree burn, third degree burn, infection of burn wound, loss of epithelium from a previously grafted or healed burn, or burn wound impetigo.

16. The method of claim 1 , wherein the tissue injury is caused during or as an adjunct to a surgical procedure.

17. The method of claim 1 , wherein the cryopreserved placental portion is administered over skin and/or dermal tissue of the subject at the site of the tissue injury to cover the tissue injury.

18. The method of claim 1 , wherein the cryopreserved placental portion is administered as an implant at the site of the tissue injury.

19. The method of claim 1 , wherein the cryopreserved placental portion reduces adhesion or fibrosis at the site of the tissue injury.

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

• C12N2501/115

  Basic fibroblast growth factor (bFGF, FGF-2) · CPC title

• C12N5/0605

  Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly · CPC title

• A61K38/57

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

• A61K38/39

  Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG] · CPC title