Method of preparing autologous cells and methods of use for therapy

• US 10,035,982 B2
• Filed: 07/31/2017
• Issued: 07/31/2018
• Est. Priority Date: 05/01/2009
• Status: Active Grant

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Rouy, Didier, Atlman, Peter A., Koziner, Benjamin
• Primary Examiner(s): Noble, Marcia S
• Application Number:
  US15/664,988
• Publication Number:
  US 20170327790A1
• Time in Patent Office: 365 Days
• CPC Class Codes: A61K 2035/124 the cells being hematopoietic, bone marrow derived or blood cells
• CPC Class Codes: A61K 35/00 Medicinal preparations containing materials or reaction products thereof with undetermined constitution
• CPC Class Codes: A61K 35/10 Peat; Amber; Turf; Humus
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: 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
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: C12N 2500/84 from mammals
• CPC Class Codes: C12N 2502/11 blood or immune system cells
• CPC Class Codes: C12N 5/0663 Bone marrow mesenchymal stem cells (BM-MSC)
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 2600/106 Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
• CPC Class Codes: C12Q 2600/156 Polymorphic or mutational markers
• CPC Class Codes: C12Q 2600/158 Expression markers

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

1. A method of treating a patient having a disease selected from the set of heart failure, myocardial ischemia, myocardial infarction, peripheral vascular disease, and an autoimmune disease, said method comprising injecting an expanded population of mesenchymal stem cells into the tissue of the patient in or near the target area of the disease thereby ameliorating an effect of the disease, said therapeutic cell population having been expanded in autologous medium as follows:

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.

2. The method of claim 1 where the injecting comprises penetrating a tip of a needle into the tissue and introducing the expanded population of mesenchymal stem cells into the tissue through the needle.

3. 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.

4. 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.

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

CD105, 73 and CD90, and the absence of CD34 and CD45.

6. The method of claim 1, wherein the expanded mesenchymal stem cells are injected interstitially into target areas through a disposable single use catheter having a distal penetrating needle tip for insertion into target areas in fluid communication with a fluid port on the proximal end of said catheter and in which the expanded mesenchymal stem cells are delivered at a concentration of between 20M and 40M cells per cc at a dosage of between 20M and 200M cells total.

7. The method of any one of claim 1 wherein the expanded mesenchymal stem cells are injected interstitially into the target areas through a catheter.