Detection of human umbilical cord tissue derived cells

• US 9,611,513 B2
• Filed: 12/20/2012
• Issued: 04/04/2017
• Est. Priority Date: 12/23/2011
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Dorai, Haimanti, Favis, Reyna L., Yao, Xiang, Sun, Yu, Kihm, Anthony J., Rassnick, Stefanie
• Primary Examiner(s): Riggs, Larry
• Assistant Examiner(s): DINES, KARLA A
• Application Number:
  US13/722,849
• Publication Number:
  US 20130190201A1
• Time in Patent Office: 1,566 Days
• Field of Search: 506 9
• CPC Class Codes: C12Q 1/6888 for detection or identification of organisms
• CPC Class Codes: G01N 2333/70589 CD45
• CPC Class Codes: G01N 33/56972 White blood cells
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92

Abstract

The invention relates to methods for detecting allogeneic therapeutic cells (such as human umbilical cord tissue-derived cells (hUTC)) in blood. The methods includes the steps of identifying one or more one or more markers positive for allogeneic therapeutic cells (e.g. hUTC) and one or more markers positive for human peripheral blood mononuclear cells (PBMC); providing a blood sample from a patient that has been treated with allogeneic therapeutic cells (e.g. hUTC), analyzing the sample using an assay method to detect one or more markers positive for PBMC and one or more markers positive for allogeneic therapeutic cells (e.g. hUTC); and distinguishing between the PBMC and one or more markers positive for allogeneic therapeutic cells (e.g. hUTC). In one embodiment, the cells are hUTC and the markers positive of hUTC include CD10 and/or CD13 and the one or more markers positive for PBMC includes CD45.

Claims

1. A method of determining the pharmacokinetic profile of human umbilical cord tissue-derived cells in patient:

a. administering a known quantity of a homogeneous population of isolated human umbilical cord tissue-derived cells of either XX or XY karyotype;

b. providing a blood sample from a male or female patient that has been treated with the known quantity of human umbilical cord tissue-derived cells;

c. testing the patient blood sample to detect one or more unique markers positive for the human umbilical cord tissue-derived cells and CD45;

d. comparing the test results to a unique marker profile for the human umbilical cord

tissue-derived cells and CD45 to distinguish between the patient peripheral blood mononuclear cells and human umbilical cord tissue-derived cells based on the detection of the unique marker profile;

e. quantifying the number of human umbilical cord tissue-derived cells; and

f. generating a pharmacokinetic profile for the treatment using the homogeneous population of isolated human umbilical cord tissue-derived cells,

wherein the unique marker profile of the human umbilical cord tissue-derived cells comprises one or more markers positive for the human umbilical cord tissue-derived cells,

wherein the unique marker profile of the human umbilical cord tissue-derived cells comprises one or more markers positive for the human umbilical cord tissue-derived cells,

wherein said one or more markers positive for the human umbilical cord tissue derived cells do not comprise CD45, and

wherein the human umbilical cord tissue-derived cells are isolated from human umbilical cord tissue substantially free of blood, are capable of self-renewal and expansion in culture, have the potential to differentiate, and have the following characteristics;

(1) express CD10, CD13, CD44, CD90, NRP1, DKK3, LAMP1, and HLA-ABC;

(2) do not express CD31, CD34, HLA-DR and CD117, and (3) do not express hTERT or telomerase.

2. The method of claim 1, further comprising performing an enrichment step between steps (b) and (c).

3. The method of claim 2 wherein the enrichment step is magnetic capture technology.

4. The method of claim 1, wherein the patient is a human, non-human primate, mouse, rat, hamster, guinea pig, dog, or pig.