# US 11,110,131 B2 · Methods and materials for treating lung disorders

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- Number: US 11,110,131 B2
- Document ID: US11110131B2
- Status: Granted
- Kind: B2
- Application number: 16/505,133
- Filed: 2019-07-08
- Published: 2019-10-31
- Granted: 2021-09-07
- Earliest claimed: 2015-01-05
- Applicants: Gary M. Petrucci
- Inventors: Gary M. Petrucci
- Web page: https://patentgrep.com/patent/US11110131B2

## CPC

- A61K 35/50: Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
- 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 9/10: Dispersions; Emulsions
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61P 11/00: Drugs for disorders of the respiratory system
- 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

## Abstract

This document provides methods and materials for treating lung conditions induced by inhalable insulin therapy. For example, compositions including a dried amnion tissue preparation and/or a dried stem cell preparation as well as methods for using such compositions to treat inhalable insulin induced lung conditions are provided.

## Claims

### Claim 1

A composition comprising:
a dried amnion tissue preparation lacking viable cells;
a dried stem cell preparation lacking viable cells, wherein the dried stem cell preparation is a dried umbilical cord-, fat tissue-, or bone marrow-derived stem cell preparation of cellular remnants from lysed stem cells; and
wherein the composition is an inhalable formulation.

### Claim 2 (depends on 1)

The composition of claim 1, wherein said dried stem cell preparation is a dried umbilical cord-derived stem cell preparation.

### Claim 3 (depends on 1)

The composition of claim 1, wherein said dried stem cell preparation and said dried amnion tissue preparation are in the form of particles ranging in size from about 0.1 μm to about 10 μm.

### Claim 4 (depends on 1)

The composition of claim 1, wherein said dried stem cell preparation and said dried amnion tissue preparation are in the form of particles ranging in size from about 1 μm to about 5 μm.

### Claim 5 (depends on 3)

The composition of claim 3, wherein the particles are coated or encapsulated.

### Claim 6 (depends on 1)

The composition of claim 1, further comprising one or more of a therapeutic agent, a growth factor, a polymer, a lipopolymer, a lung surfactant, and a pharmaceutical excipient.

### Claim 7

A method for treating a lung disorder, the method comprising:
administering to a lung of a subject an inhalable formulation comprising a dried amnion tissue preparation lacking viable cells, and a dried stem cell preparation lacking viable cells, wherein the dried stem cell preparation is a dried umbilical cord-, fat tissue-, or bone marrow-derived stem cell preparation of cellular remnants from lysed stem cells wherein the lung disorder is selected from the group consisting of bronchospasms, asthma, COPD, chronic bronchitis, emphysema, pulmonary hypertension, asthma, interstitial lung disease, acute respiratory distress syndrome, pneumonia, lung infections, pulmonary fibrosis, and combinations thereof.

### Claim 8 (depends on 1)

A method comprising:
treating a mammal having a lung disorder by administering, to the mammal via inhalation, the composition of claim 1, wherein the lung disorder is selected from the group consisting of bronchospasms, asthma, COPD, chronic bronchitis, emphysema, pulmonary hypertension, asthma, interstitial lung disease, acute respiratory distress syndrome, pneumonia, lung infections, pulmonary fibrosis, and combinations thereof.

### Claim 9 (depends on 8)

The method of claim 8, wherein treating the mammal results in an improvement or elimination of one or more symptoms associated with the mammal's lung disorder.

### Claim 10 (depends on 1)

The composition of claim 1, further comprising one or more of an anti-inflammatory agent and an antimicrobial agent.

### Claim 11 (depends on 7)

The method of claim 7, wherein the inhalable formulation further comprises one or more of a therapeutic agent, a growth factor, a polymer, a lipopolymer, a lung surfactant, and a pharmaceutical excipient.

### Claim 12 (depends on 7)

The method of claim 7, wherein the inhalable formulation further comprises one or more of an anti-inflammatory agent and an antimicrobial agent.

### Claim 13 (depends on 7)

The method of claim 7, wherein the dried stem cell preparation is a dried umbilical cord-derived stem cell preparation.

### Claim 14 (depends on 7)

The method of claim 7, wherein the dried stem cell preparation and said dried amnion tissue preparation are in the form of particles ranging in size from about 0.1 μm to about 10 μm.

### Claim 15 (depends on 7)

The method of claim 7, wherein the dried stem cell preparation and said dried amnion tissue preparation are in the form of particles ranging in size from about 1 μm to about 5 μm.

### Claim 16 (depends on 7)

The method of claim 7, wherein the inhalable formulation comprises from about 1 mg and about 5 g of said dried amnion tissue preparation per Kg body weight of the subject being treated.

### Claim 17 (depends on 7)

The method of claim 7, wherein the inhalable formulation comprises from about 10 mg and about 1 g of said dried amnion tissue preparation per Kg body weight of the subject being treated.

### Claim 18 (depends on 7)

The method of claim 7, wherein the inhalable formulation is coated or encapsulated.
