# US 12,005,153 B2 · Compositions and methods for treating wounds

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- Number: US 12,005,153 B2
- Document ID: US12005153B2
- Status: Granted
- Kind: B2
- Application number: 16/663,337
- Filed: 2019-10-25
- Published: 2020-05-28
- Granted: 2024-06-11
- Earliest claimed: 2014-10-14
- Assignees: Samuel E. Lynch
- Applicants: Samuel Lynch
- Inventors: Samuel E. Lynch
- Web page: https://patentgrep.com/patent/US12005153B2

## CPC

- A61L 26/0066: {Medicaments; Biocides}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)}
- A61K 38/1858: {Platelet-derived growth factor [PDGF]}
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34)
- A61L 15/325: {Collagen}
- A61L 15/425: {Porous materials, e.g. foams or sponges}
- A61L 15/44: Medicaments
- A61L 15/46: Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
- A61L 26/0023: {Polysaccharides}
- A61L 26/0033: {Collagen}
- A61L 26/0052: {Mixtures of macromolecular compounds}
- A61L 26/0085: {Porous materials, e.g. foams or sponges}
- A61L 26/0095: {Composite materials, i.e. containing one material dispersed in a matrix of the same or different material}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61L 2300/206: Biguanides, e.g. chlorohexidine
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/406: Antibiotics
- A61L 2300/414: Growth factors
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

An improvement to the effectiveness or “take” of skin grafts or tissue replacements used to treat wounds is provided. A therapeutic composition comprising recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a porous biocompatible carrier is first applied to the wound surface, followed by applying a skin substitute or tissue replacements composition.

## Claims

### Claim 1

A method of treating a skin wound, the method comprising:
(1) treating the wound surface by applying a sterile therapeutic composition consisting essentially of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) optionally in a physiologic solution and a porous biocompatible carrier to the wound surface, wherein the porous biocompatible carrier is a collagen sponge or collagen wound dressing or a gelatin, and wherein the carrier provides a substrate for cell attachment and vascular ingrowth as the wound heals, and said applying delivers at least about 10 μg rhPDGF-BB per cm2 of treated wound surface area up to 100 μg rhPDGF-BB per cm2 treated wound surface area, optionally wherein prior to treating the wound surface the wound is debrided to remove necrotic or infected tissue;
(2) optionally covering the wound with a dressing;
(3) optionally using a treatment regimen of repeating steps (1) - (2) for 2 to 20 times at treatment intervals of three or more days; and
(4) applying a skin-substitute composition to the treated wound and optionally covering the wound with a second dressing.

### Claim 2 (depends on 1)

The method of claim 1, wherein steps (1) - (2) are repeated until granulation tissue covers the treated wound surface.

### Claim 3 (depends on 1)

The method of claim 1, where the treatment regimen lasts no more than 7, 14, 21, 28, 35, 42, 50, 60, 70, 80, or 90 days.

### Claim 4 (depends on 1)

The method of claim 1, wherein the treatment intervals are up to 7, 10, 14, or 21 days.

### Claim 5 (depends on 1)

The method of claim 1, wherein the skin wound is a chronic ulcerated wound.

### Claim 6 (depends on 5)

The method of claim 5, wherein the chronic ulcerated wound is selected from the group consisting of a venous ulcer (VU), venous leg ulcer (VLU), arterial/venous ulcer, arterial ulcer, diabetic foot ulcer (DFU), posttraumatic ulcer, and pressure ulcer.

### Claim 7 (depends on 1)

The method of claim 1, wherein the skin wound is caused by thermal trauma.

### Claim 8 (depends on 1)

The method of claim 1, wherein the skin wound is caused by surgery.

### Claim 9 (depends on 1)

The method of claim 1, wherein the skin wound is partial thickness, full thickness, or deep wound.

### Claim 10 (depends on 1)

The method of claim 1, wherein the wound surface area is greater than about 1 cm2.

### Claim 11 (depends on 1)

The method of claim 1, wherein the porous biocompatible carrier has a pore size distribution of between about 10 microns to about 2,000 microns.

### Claim 12 (depends on 1)

The method of claim 1, wherein the porous biocompatible carrier has an average pore size of between about 50 microns to about 500 microns.

### Claim 13 (depends on 1)

The method of claim 1, wherein the collagen sponge or collagen wound dressing comprises animal-sourced collagen.

### Claim 14 (depends on 1)

The method of claim 1, wherein the collagen sponge or collagen wound dressing comprises at least 90% Type I collagen, at least 10% type Ill collagen, hydrolyzed collagen, monomeric collagen, or crosslinked collagen.

### Claim 15 (depends on 1)

The method of claim 1, wherein the collagen sponge or collagen wound dressing comprises lyophilized collagen or gel-form collagen.

### Claim 16 (depends on 1)

The method of claim 1, wherein the porous biocompatible carrier comprises an analgesic or antibiotic.

### Claim 17 (depends on 1)

The method of claim 1, wherein the porous biocompatible carrier comprises an antiseptic.

### Claim 18 (depends on 1)

The method of claim 1, wherein the wound dressing in step (1) or the dressing for covering the wound in steps (2) and (4) contains an analgesic or antibiotic.

### Claim 19 (depends on 1)

The method of claim 1, wherein the wound dressing in step (1) or the dressing for covering the wound in steps (2) and (4) contains an antiseptic.

### Claim 20 (depends on 19)

The method of claim 19, wherein the antiseptic is silver, polyhexarnethylene biguanide (PHMB), or polyhexadine.

### Claim 21 (depends on 1)

The method of claim 1, wherein the skin-substitute composition comprises living cells.

### Claim 22 (depends on 21)

The method of claim 21, wherein the living cells are stem cells.

### Claim 23 (depends on 22)

The method of claim 22, wherein the stem cells are selected from the group consisting of mesenchymal stem cells, hematopoietic stem cells, epithelial stem cells, bone marrow stem cells, and adipose-derived stem cells.

### Claim 24 (depends on 22)

The method of claim 22, wherein the stem cells are at a dose of about 1,500 to about 30,000, or about 2,000 to about 25,000, or about 2,500 to about 20,000 stem cells per square centimeter of would surface.

### Claim 25 (depends on 22)

The method of claim 22, wherein the overall dosage of the stem cells per treatment is about 1 million to about 10 million, or about 3 million to about 8 million, or about 4 million to about 6 million stem cells.

### Claim 26 (depends on 22)

The method of claim 22 wherein the method further comprises injecting into or around the wound at least one additional dose of stem cells to treat the wound at least 7 days or at least 14 days or at least 21 days following the initial treatment.

### Claim 27 (depends on 21)

The method of claim 21, wherein the living cells comprise one or more of epithelial cells, endothelial cells, keratinocytes, fibroblasts, adipose-derived stromal vascular fraction (SVF) cells, and platelets.

### Claim 28 (depends on 27)

The method of claim 27, wherein the living cells comprise epithelial cells.

### Claim 29 (depends on 21)

The method of claim 21, wherein the living cells comprise cultured cells.

### Claim 30 (depends on 1)

The method of claim 1, wherein the skin-substitute composition comprises mesenchymal stem cells, epithelial cells, or keratinocytes.

### Claim 31 (depends on 1)

The method of claim 1, wherein said skin-substitute composition comprises a biodegradable synthetic component.

### Claim 32 (depends on 1)

The method of claim 1, wherein the skin-substitute composition comprises an autologous, allogenic, or xenogenic skin graft.

### Claim 33 (depends on 32)

The method of claim 32, wherein the autologous, allogenic, or xenogenic skin graft is a split-thickness skin graft (STSG).

### Claim 34 (depends on 32)

The method of claim 32, wherein the autologous, allogenic, or xenogenic skin graft is a full-thickness skin graft (FTSG) or a full-thickness skin tissue column (FTSTC).

### Claim 35 (depends on 1)

The method of claim 1, wherein the skin-substitute composition is applied topically to the wound surface by placing or injecting the skin-substitute composition onto the wound surface.

### Claim 36 (depends on 2)

The method of claim 2, wherein the skin-substitute composition is applied over the granulation tissue covering the treated wound surface.

### Claim 37 (depends on 1)

The method of claim 1, wherein said skin-substitute composition provides a permanent, semi-permanent, or temporary cover for the skin wound.

### Claim 38 (depends on 1)

The method of claim 1, wherein the sterile therapeutic composition is free from an enzyme inhibitor.