# US 12,599,633 B2 · Mesenchymal stem cells for use in the treatment of skin defects

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- Number: US 12,599,633 B2
- Document ID: US12599633B2
- Status: Granted
- Kind: B2
- Application number: 18/560,712
- Filed: 2022-05-20
- Published: 2024-07-25
- Granted: 2026-04-14
- Earliest claimed: 2021-05-20
- Assignees: Xintela AB
- Applicants: Xintela AB
- Inventors: Evy Lundgren Åkerlund; Folke Sjöberg; Hooi Ching Lim; Ahmed Elserafy; Moustafa Elmasry
- Web page: https://patentgrep.com/patent/US12599633B2

## CPC

- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- 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 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 9/10: Dispersions; Emulsions
- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take 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)
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61Q 19/00: Preparations for care of the skin
- 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
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## Abstract

The present invention relates to therapeutics and methods for treating skin defects using compositions comprising integrin al0-selected Mesenchymal Stem Cells (MSCs) Disclosed herein are integrin α10-selected MSC populations and culture conditions that enhance cell viability, paracrine activity, and regenerative function when administered to damaged skin tissue. The compositions promote wound healing, modulate inflammatory responses, and support re-epithelialization. Further disclosed herein are dosing parameters and administration routes suitable for improving healing outcomes in acute and chronic skin defects.

## Claims

### Claim 1

A method for treatment and/or regeneration of a skin defect, comprising administering a therapeutically effective amount of a composition comprising integrin alpha10-selected Mesenchymal Stem Cells (MSCs) to a subject in need thereof, wherein at least 60% of the MSCs express integrin alpha10 subunit.

### Claim 2

A method for prevention of fibrosis of the skin comprising administering a therapeutically effective amount of a composition comprising integrin alpha10-selected Mesenchymal Stem Cells (MSCs) to a subject in need thereof.

### Claim 3

A method for regeneration of skin at the site of a skin defect and/or for reducing scar formation resulting from healing of a skin defect comprising administering a composition comprising integrin alpha10-selected Mesenchymal Stem Cells (MSCs) to a subject in need thereof.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the skin defect is a hard-to-heal wound.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the hard-to-heal wound is a chronic wound.

### Claim 6 (depends on 4)

The method according to claim 4, wherein the hard-to-heal wound is associated with venous insufficiency, arterial insufficiency and diabetic complications, a rare disease, or is a pressure-related hard-to-heal wound.

### Claim 7 (depends on 4)

The method according to claim 4, wherein the hard-to-heal wound is a dermal ulcer, a wound, or a skin defect due to vascular insufficiency or diabetic affection of the blood vessels.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the skin defect is a skin disorder provoked by external factors, an inflammatory dermatosis, a postprocedural disorder of the skin, or a genetic and/or developmental disorder affecting the skin.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the skin disorder provoked by external factors is selected from a pressure ulceration, dermatoses provoked by friction or mechanical stress, dermatoses due to foreign bodies, dermatoses provoked or exacerbated by exposure to cold, dermatoses provoked by heat or electricity, dermatoses provoked by light or UV radiation, dermatoses due to ionizing radiation, allergic contact dermatitis, photo-allergic contact dermatitis, irritant contact dermatitis, allergic contact urticarial, protein contact dermatitis, allergic contact sensitization, phototoxic reactions to skin contact with photoactive agents, cutaneous reactions to venomous or noxious animals, a burn, a pressure sore from extended bed rest, a skin defect induced by trauma, and a cut.

### Claim 10 (depends on 8)

The method according to claim 8, wherein the inflammatory dermatosis is selected from a dermatitis, eczema, atopic dermatitis, papulosquamous dermatoses, urticaria, angioedema or other urticarial disorders, inflammatory erythemas and other reactive inflammatory dermatoses, immunobullous diseases of the skin, cutaneous lupus erythematosus, and scarring or sclerosing inflammatory dermatoses.

### Claim 11 (depends on 8)

The method according to claim 8, wherein the postprocedural disorder of the skin is an unsatisfactory surgical scar of skin, a cutaneous flap necrosis, a myocutaneous flap necrosis, a skin graft failure, a composite graft failure, or a surgical incision.

### Claim 12 (depends on 8)

The method according to claim 8, wherein the genetic and/or developmental disorder affecting the skin is epidermolysis bullosa or genodermatosis.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the composition is administered topically to the skin defect, via injection, or a combination thereof.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the composition is dosed to comprise between 20.000 and 150.000 MSCs/cm2 of skin defect to be treated.

### Claim 15 (depends on 1)

The method according to claim 1, wherein the composition is administered in the form of a cell suspension in a pharmaceutically acceptable liquid medium.

### Claim 16 (depends on 1)

The method according to claim 1, wherein the composition is administered on a dressing or reservoir.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the MSCs are MHCII negative, CD45 negative, CD34 negative, CD11b negative, CD19 negative and/or CD79 alpha negative; and/or wherein the MSCs express CD73, CD90 and/or CD105.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the MSCs are an in vitro cell suspension.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the MSCs have been selected by their expression of integrin alpha10 with an anti-integrin alpha10 antibody.

### Claim 20 (depends on 1)

The method according to claim 1, wherein the MSCs are allogeneic or autologous.