# US 9,750,769 B2 · Stable neural stem cells comprising an exogenous polynucleotide coding for a growth factor and methods of use thereof

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- Number: US 9,750,769 B2
- Document ID: US9750769B2
- Status: Granted
- Kind: B2
- Application number: 14/886,272
- Filed: 2015-10-19
- Published: 2016-05-05
- Granted: 2017-09-05
- Earliest claimed: 2014-10-20
- Assignees: Neuralstem, Inc.
- Applicants: Neuralstem, Inc.
- Inventors: Thomas Hazel; Karl K. Johe
- Web page: https://patentgrep.com/patent/US9750769B2

## CPC

- 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 38/30: Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2 {(insulin-like growth factor binding protein A61K38/1754)}
- A61K 48/00: Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/02: for peripheral neuropathies
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- C12N 5/0618: {Cells of the nervous system}
- C12N 5/0623: {Stem cells}
- C12N 5/10: Cells modified by introduction of foreign genetic material
- C07K 14/65: Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

The present disclosure provides a human neural stem cell comprising an exogenous polynucleotide coding for a growth factor such as IGF-1. Also disclosed are methods of using the human neural stem cells for the treatment of neurodegenerative diseases or disorders including, for example, ALS.

## Claims

### Claim 1

A human neural stem cell comprising a vector containing an exogenous polynucleotide coding for insulin-like growth factor 1 (IGF-1), wherein IGF-1 comprises a nucleotide sequence as set forth in SEQ ID NO: 1, and wherein the IGF-1 nucleotide sequence is stably expressed, and wherein the human neural stem cell is expandable for more than sixty cell doublings without undergoing differentiation.

### Claim 2 (depends on 1)

The human neural stem cell of claim 1, wherein the exogenous polynucleotide coding for IGF-1 is operably linked to a ubiquitin C (UbC) promoter, a human phosphoglycerate kinase 1 promoter, a human synapsin promoter, or a synthetic CAG promoter.

### Claim 3 (depends on 1)

The human neural stem cell of claim 1, wherein the stem cell differentiates into a significantly increased number of GAD65-positive GABAergic neurons compared to a neural stem cell that does not comprise an exogenous polynucleotide coding for IGF-1.

### Claim 4 (depends on 1)

The human neural stem cell of claim 1, wherein the human neural stem cell is obtained from a fetus or an embryo.

### Claim 5 (depends on 4)

The human neural stem cell of claim 4, wherein the human neural stem cell is obtained from a fetus having a gestational age of about 5 to about 20 weeks.