# US 10,765,705 B2 · Visco-supplement compositions, and methods of use thereof

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- Number: US 10,765,705 B2
- Document ID: US10765705B2
- Status: Granted
- Kind: B2
- Application number: 14/950,186
- Filed: 2015-11-24
- Published: 2016-05-26
- Granted: 2020-09-08
- Earliest claimed: 2014-11-24
- Assignees: Prime Merger Sub, LLC
- Applicants: Prime Merger Sub, LLC
- Inventors: Robin R. Young
- Web page: https://patentgrep.com/patent/US10765705B2

## CPC

- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 35/30: Nerves; Brain; Eyes; Corneal cells; Cerebrospinal fluid; Neuronal stem cells; Neuronal precursor cells; Glial cells; Oligodendrocytes; Schwann cells; Astroglia; Astrocytes; Choroid plexus; Spinal cord tissue
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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

Visco-supplement compositions derived from a transcellular fluid, such as human amniotic fluid, human aqueous humor fluid, or human vitreous fluid are described. Also described are methods for treating inflammatory conditions of the musculoskeletal system, such as joint inflammation, and methods of lubricating a joint using the described visco-supplement compositions.

## Claims

### Claim 1

A visco-supplement composition comprising a processed transcellular fluid, wherein the processed transcellular fluid comprises:
(a) an increased concentration of at least one of a first component selected from the group consisting of proteins, lipids, and carbohydrates as compared to a concentration of the first component in an unprocessed transcellular fluid; and
(b) a decreased concentration of at least one of a second component selected from the group consisting urea, uric acid, and creatinine, as compared to a concentration of the second component in the unprocessed transcellular fluid,
and the composition has a pH in a range of about 6.0 to about 8.0,
wherein the processed transcellular fluid includes 30.25 g/L to 50.375 g/L of proteins, 0.25 g/L to 6.5 g/L of fatty acids, 0.5 g/L to 9.5 g/L of cholesterol, 0.003 g/L to 0.3 g/L of phospholipids, glucose at a concentration of 600 mg/L to 900 mg/L, fructose at a concentration of 48 mg/L to 59 mg/L, hyaluronic acid at a concentration of 30 μg/L to 3600 μg/L,, lubricin at a concentration of 10 μg/ml to 200 μg/ml, no more than 160 mg/L of urea, no more than 80 g/L of uric acid and no more than 14 mg/L of creatinine.

### Claim 2 (depends on 1)

The visco-supplement composition according to claim 1, wherein the unprocessed transcellular fluid is a human transcellular fluid.

### Claim 3 (depends on 1)

The visco-supplement composition according to claim 1, wherein the unprocessed transcellular fluid is selected from the group consisting of an amniotic fluid, aqueous humor fluid, and vitreous humor fluid.

### Claim 4 (depends on 1)

The visco-supplement composition according to claim 1, further comprising a cryoprotectant.

### Claim 5 (depends on 4)

The visco-supplement composition according to claim 4, wherein the cryoprotectant is selected from the group consisting of dimethylsulfoxide (DMSO), glucose, sucrose, glycerol, and combinations thereof.

### Claim 6 (depends on 1)

The visco-supplement composition according to claim 1, wherein the first component is a protein selected from the group consisting of interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor (TNF)-α.

### Claim 7 (depends on 1)

The visco-supplement composition according to claim 1, wherein the first component is a lipid selected from the group consisting of fatty acids, cholesterol, and phospholipids.

### Claim 8 (depends on 1)

The visco-supplement composition according to claim 1, wherein the first component is a carbohydrate selected from the group consisting of glucose, fructose, hyaluronic acid, and lubricin.

### Claim 9 (depends on 1)

The visco-supplement composition according to claim 1, wherein the composition is substantially free of particulate matter.

### Claim 10 (depends on 1)

The visco-supplement of claim 1 wherein the processed transcellular fluid includes 48.125 mg/L to 58.625 mg/L of fructose.

### Claim 11 (depends on 1)

The visco-supplement of claim 1 wherein the processed transcellular fluid includes 156.25 mg/L to 250 mg/L of lactic acid.

### Claim 12 (depends on 1)

The visco-supplement of claim 1 wherein the processed transcellular fluid includes 11 mg/L to 13.4 mg/L of pyruvate.

### Claim 13 (depends on 1)

The visco-supplement of claim 1, wherein the processed transcellular fluid includes at least 329 ng/L of IL-6, at least 421 ng/L of IL-8, at least 3.9 ng/L of IL-10 and at least 11.5 ng/L of TNF-α.
