# US 12,109,241 B2 · Methods of manufacture of immunocompatible chorionic membrane products

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- Number: US 12,109,241 B2
- Document ID: US12109241B2
- Status: Granted
- Kind: B2
- Application number: 18/094,148
- Filed: 2023-01-06
- Published: 2023-11-30
- Granted: 2024-10-08
- Earliest claimed: 2010-02-18
- Assignees: Osiris Therapeutics, Inc.
- Applicants: Osiris Therapeutics, Inc.
- Inventors: Samson Tom; Alla Danilkovitch; Dana Yoo; Timothy Jansen; Jin-Qiang Kuang; Jennifer Michelle Marconi
- Web page: https://patentgrep.com/patent/US12109241B2

## CPC

- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A01N 1/125: Freeze protecting agents, e.g. cryoprotectants or osmolarity regulators
- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- A61K 38/1825: {Fibroblast growth factor [FGF]}
- A61K 38/1841: {Transforming growth factor [TGF]}
- A61K 38/39: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- A61K 38/57: from animals; from humans {(A61K38/553, A61K38/556 take precedence)}
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 5/0605: {Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly}
- C12N 2500/02: Atmosphere, e.g. low oxygen conditions
- C12N 2501/115: Basic fibroblast growth factor (bFGF, FGF-2)
- C12N 2502/025: extra-embryonic cells, e.g. amniotic epithelium, placental cells, Wharton's jelly
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## 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.

## Claims

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

The method of claim 1, wherein the cryopreserved placental portion has 20,000 to about 200,000 cells per cm2.

### Claim 12 (depends on 1)

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

### Claim 13 (depends on 12)

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.

### Claim 14 (depends on 1)

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

### Claim 15 (depends on 14)

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.

### Claim 16 (depends on 1)

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

### Claim 17 (depends on 1)

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.

### Claim 18 (depends on 1)

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

### Claim 19 (depends on 1)

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