# US 11,439,668 B2 · Methods to differentiate stem cells into hormone-producing cells

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- Number: US 11,439,668 B2
- Document ID: US11439668B2
- Status: Granted
- Kind: B2
- Application number: 15/947,304
- Filed: 2018-04-06
- Published: 2018-08-09
- Granted: 2022-09-13
- Earliest claimed: 2014-05-23
- Assignees: JangoBio, LLC
- Applicants: JangoBio, LLC
- Inventors: Craig S. Atwood; Sivan Vadakkadath Meethal
- Web page: https://patentgrep.com/patent/US11439668B2

## CPC

- A61K 35/545: Embryonic stem cells; Pluripotent stem cells; Induced pluripotent stem cells; Uncharacterised stem cells
- A61K 31/566: having an oxo group in position 17, e.g. estrone
- A61K 31/568: substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K 35/15: Cells of the myeloid line, e.g. granulocytes, basophils, eosinophils, neutrophils, leucocytes, monocytes, macrophages or mast cells; Myeloid precursor cells; Antigen-presenting cells, e.g. dendritic cells (presenting a specific antigen A61K39/00; therapeutic combinations of antibodies, or fragments thereof, and blood-derived cells A61K39/00)
- A61K 35/52: Sperm; Prostate; Seminal fluid; Leydig cells of testes
- A61K 35/54: Ovaries; Ova; Ovules; Embryos; Foetal cells; Germ cells
- A61K 35/55: Glands not provided for in groups A61K35/22 - A61K35/545, e.g. thyroids, parathyroids or pineal glands
- A61P 5/06: of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
- A61P 5/24: of the sex hormones
- C07K 14/59: Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
- 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)}
- C12N 5/0606: {Pluripotent embryonic cells, e.g. embryonic stem cells [ES] (embryonic germ cells C12N5/0611, induced pluripotent stem cells C12N5/0696)}
- C12N 5/0608: {Germ cells (production of embryos, nuclear transfer A01K67/027)}
- 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
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Methods are described for differentiating stem and post-natal cells into sex hormone-producing cells that can be administered to a patient autologously or allogeneically in order to maintain in balance, or rebalance, their hypothalamic-pituitary-gonadal (HPG) axis.

## Claims

### Claim 1

A method of differentiating cells, the method comprising:
incubating mesenchymal stem cells with a combination of SF-1 and WT1 agonists and inverse agonists to induce the cells to differentiate into gonadal hormone- producing cells.

### Claim 2 (depends on 1)

A method of reducing endocrine dyscrasia (dyosis) in a patient, comprising:
maintaining or rebalancing a hypothalamic-pituitary-gonadal (HPG) axis of the patient in need thereof by administering a therapeutically effective amount of the gonadal hormone- producing cells according to the method of claim 1.

### Claim 3 (depends on 2)

The method according to claim 2 wherein the ratios of hormones in the HPG axis of the patient are maintained at or near a ratio occurring during fetal life or at or near the time of greatest reproductive function of the patient.

### Claim 4 (depends on 3)

The method according to claim 3 wherein the sex steroids, inhibins and follistatin of the patient are regulated to be at the ratio near the blood and/or tissue levels, production, function and activity occurring during fetal life or at or near the time of greatest reproductive function of the patient.

### Claim 5 (depends on 3)

The method according to claim 3 wherein the kisspeptin, neurokinin B, dynorphin. kit ligand, AIVIH GnRH LH, FSH and activins are regulated to be at the ratio near the blood and/or tissue levels, production, function and activity occurring during fetal life or at or near the time of greatest reproductive function of the patient.