# US 12,213,995 B2 · Preparations comprising mesenchymal stem cells and cannabinoids and methods of their use

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- Number: US 12,213,995 B2
- Document ID: US12213995B2
- Status: Granted
- Kind: B2
- Application number: 17/628,011
- Filed: 2020-07-20
- Published: 2022-08-18
- Granted: 2025-02-04
- Earliest claimed: 2019-07-18
- Assignees: Direct Biologics, LLC
- Applicants: Direct Biologics, LLC
- Inventors: Kenneth Allen Pettine; Timothy Alexander Moseley
- Web page: https://patentgrep.com/patent/US12213995B2

## CPC

- A61K 9/0073: {Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M)}
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- 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)

## Abstract

Disclosed are compositions comprising a MSC secretome preparation and cannabinoids and methods of the use of said compositions for the treatment of inflammatory conditions.

## Claims

### Claim 1

A composition comprising:
i) a mesenchymal stem cell (MSC) secretome preparation comprising MSC growth factors, MSC extracellular vesicles, MSC exosomes, and/or MSC extracts; and
ii) a cannabinoid;
wherein the MSC growth factors, MSC extracellular vesicles, MSC exosomes, and/or MSC extracts are obtained from human bone-marrow MSCs cultured under conditions comprising about 0.1% to about 5% oxygen and an acidic pH of 6.2 to 6.9.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the cannabinoid is cannabidiol (CBD) or Cannabigerol (CBG).

### Claim 3 (depends on 1)

A method of treating an inflammatory condition, an autoimmune disease, an autoinflammatory disease, metabolic disorder, or inflammation in a subject, the method comprising administering to the subject a therapeutically effective amount of the composition of claim 1.

### Claim 4

A method of treating an inflammatory condition, an autoimmune disease, an autoinflammatory disease, or metabolic disorder, in a subject, the method comprising culturing bone-marrow mesenchymal stem cells (MSCs) under conditions comprising about 0.1% to about 5% oxygen and an acidic pH of 6.2 to 6.9 to generate a mesenchymal stem cell (MSC) secretome preparation, and administering to the subject a therapeutically effective amount of the MSC secretome preparation and a cannabinoid.

### Claim 5 (depends on 4)

The method of claim 4, wherein the MSC secretome preparation and the cannabinoid are administered in the same composition.

### Claim 6 (depends on 4)

The method of claim 4, wherein the MSC secretome preparation is administered via inhalation.

### Claim 7 (depends on 4)

The method of claim 4, wherein the MSC secretome preparation and the cannabinoid are administered via inhalation.

### Claim 8

A method of treating inflammation in a subject, the method comprising culturing bone-marrow mesenchymal stem cells (MSCs) under conditions comprising about 0.1% to about 5% oxygen and an acidic pH of 6.2 to 6.9 to generate a mesenchymal stem cell (MSC) secretome preparation and administering to the subject a therapeutically effective amount of the MSC secretome preparation and a cannabinoid.