# US 9,752,123 B2 · Method of preparing autologous cells and methods of use for therapy

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- Number: US 9,752,123 B2
- Document ID: US9752123B2
- Status: Granted
- Kind: B2
- Application number: 15/055,418
- Filed: 2016-02-26
- Published: 2016-08-11
- Granted: 2017-09-05
- Earliest claimed: 2009-05-01
- Assignees: BioCardia, Inc.
- Applicants: BioCardia, Inc.
- Inventors: Didier Rouy; Peter A. Atlman; Benjamin Koziner
- Web page: https://patentgrep.com/patent/US9752123B2

## CPC

- C12N 5/0663: {Bone marrow mesenchymal stem cells (BM-MSC)}
- 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 35/00: Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K 35/10: Peat; Amber; Turf; Humus
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61K 2035/124: {the cells being hematopoietic, bone marrow derived or blood cells}
- C12N 2500/84: from mammals
- C12N 2502/11: blood or immune system cells
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/156: Polymorphic or mutational markers
- C12Q 2600/158: Expression markers
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

A method for expanding mesenchymal cells derived from autologous bone marrow in autologous culture medium which can be used in a clinical setting, and a business method for performing such expansions in the future as a service for patients. A method for expanding mesenchymal cells derived from autologous bone marrow in autologous culture medium including a diagnostic kit for the autologous cell therapy to determine whether a patient will respond to the autologous cell therapy for treatment of a disease, in which said kit comprising a system for detecting gene and protein expression comprising at least two isolated DNA molecules wherein each isolated DNA molecule detects expression of a gene that is differentially expressed in the tissue of the patient that is intended to be the source of the autologous cell therapy.

## Claims

### Claim 1

A method of preparing a therapeutic cell population expanded in autologous medium comprising:
harvesting blood from a donor in two visits separated between one and three weeks;
harvesting bone marrow cells from the donor;
forming a culture medium from said blood that contains no animal serum and comprises 10% autologous serum obtained from the donor; and
expanding a population of mesenchymal stem cells from the bone marrow cells in the culture medium.

### Claim 2 (depends on 1)

The method of claim 1, wherein the population of mesenchymal stem cells is phenotypically characterized by the presence of the following surface markers: CD105, CD73 and CD90.

### Claim 3 (depends on 1)

The method of claim 1, wherein the population of mesenchymal stem cells is phenotypically characterized by the absence of the following surface markers: CD34 and CD45.

### Claim 4 (depends on 1)

The method of claim 1, wherein the population of mesenchymal stem cells is phenotypically characterized by the presence of the following surface markers: CD 105, 73 and CD90, and the absence of CD34 and CD45.