IP Library › Granted Patent US 12,730,106
Granted Patent B2
US 12,730,106 · App. 17/286,154 · Granted Sep 8, 2026

Method for monitoring autoimmune disease

Inventors: Lonnie D. Shea (Ann Arbor, MI); Robert S. Oakes (College Park, MD); Aaron Morris (Ann Arbor, MI); Kevin Hughes (Ann Arbor, MI)
Assignee: THE REGENTS OF THE UNIVERSITY OF MICIGAN
G01N33/564A61K45/06C12Q1/68C12Q1/6883G01N33/53G01N33/5308G01N33/6863G01N33/74G01N33/96G06N20/00C12Q2600/158G01N2800/24G01N2800/285
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Quick Facts
Patent No.
US 12,730,106
App. No.
17/286,154
Granted
Sep 8, 2026
Kind
B2
Abstract

Provided herein are methods of monitoring progression, regression, or stage of an AID in a subject, measuring a level of expression of a gene, an RNA, or a protein, or a combination thereof, in a sample obtained from a niche at the implantation site of a synthetic scaffold in the subject at a first time point and at a second time point, wherein the expression level measured at the first time point is compared to the expression level measured at the second time point, wherein the difference in the level of expression at the second time point relative to the level of expression at the first time point is indicative of progression, regression, or stage of the autoimmune disease. Related methods of detecting an AID, determining treatment for a subject with an AID, determining efficacy of an AID treatment, or treating an AID, are further provided.

Claims (19)

1 . A method comprising measuring a level of expression of a gene in a sample obtained from a niche at an implantation site of a synthetic scaffold in a mammalian subject, wherein the synthetic scaffold comprises poly(e-caprolactone) (PCL), poly(lactide-co-glycolide) (PLG), poly(ethylene glycol) (PEG), and/or alginate, wherein the mammalian subject has or is suspected of having an autoimmune disease selected from multiple sclerosis and diabetes, and wherein:

(a) when the subject has or is suspected of having multiple sclerosis, the method comprises measuring the level of expression of:

(i) one or more of PRTN3, ELA2, LTF, CAMP, CHI3L3, S100A8, S100A9, IL8RB, CSF3, H2Q10, CD55, LEFTY, CCL22, IL12B, FOXP3, CXCR3, KLRG1, CCL24, PROCR, and MASP, or

(ii) one or more of FN1, LIF, BDKRB1, TNFRSF11B, CFB, OLR1, CLEC7A, CXCL5, PTGS2, CXCL3, IL1F9, IL1B, TRM1, CXCL2, S100A9, CXCL1, IL6, EREG, VEGFA, CD163, and ADRB2; and

(b) when the subject has or is suspected of having diabetes, the method comprises measuring the level of expression of one or more of CD163, PTGS2, TNFRSF11B, VEGFA, FN1, IL6, BDKRB1, S100A9, CXCL1, CXCL3, CFB, CLEC7A, IL1B, IL1F9, CXCL5, OLR1, LIF, CXCL2, TREM1, EREG, and ADRB2.

2 . The method of claim 1 , wherein the subject has received at least one treatment for the autoimmune disease.

3 . The method of claim 1 , comprising measuring the level of expression of the gene in a first sample obtained from the niche at a first time point and in a second sample obtained from the niche at a second time point, wherein the second time point is after the first time point.

4 . The method of claim 3 , wherein the subject has received at least one treatment for the autoimmune disease in between the first time point and the second time point.

5 . The method of claim 1 , wherein the multiple sclerosis is relapsing-remitting multiple sclerosis.

6 . The method of claim 1 , further comprising quantifying cell populations in the sample.

7 . The method of claim 1 , wherein the subject has or is suspected of having multiple sclerosis, and the method comprises measuring the level of expression of at least three of PRTN3, ELA2, LTF, CAMP, CHI3L3, S100A8, S100A9, IL8RB, CSF3, H2Q10, CD55, LEFTY, CCL22, IL12B, FOXP3, CXCR3, KLRG1, CCL24, PROCR, and MASP.

8 . The method of claim 7 , comprising measuring the level of expression of at least five of PRTN3, ELA2, LTF, CAMP, CHI3L3, S100A8, S100A9, IL8RB, CSF3, H2Q10, CD55, LEFTY, CCL22, IL12B, FOXP3, CXCR3, KLRG1, CCL24, PROCR, and MASP.

9 . The method of claim 7 , comprising measuring the level of expression of at least eight of PRTN3, ELA2, LTF, CAMP, CHI3L3, S100A8, S100A9, IL8RB, CSF3, H2Q10, CD55, LEFTY, CCL22, IL12B, FOXP3, CXCR3, KLRG1, CCL24, PROCR, and MASP.

10 . The method of claim 1 , wherein the subject has or is suspected of having multiple sclerosis, and the method comprises measuring the level of expression of at least three of FN1, LIF, BDKRB1, TNFRSF11B, CFB, OLR1, CLEC7A, CXCL5, PTGS2, CXCL3, IL1F9, IL1B, TRM1, CXCL2, S100A9, CXCL1, IL6, EREG, VEGFA, CD163, and ADRB2.

11 . The method of claim 10 , comprising measuring the level of expression of at least five of FN1, LIF, BDKRB1, TNFRSF11B, CFB, OLR1, CLEC7A, CXCL5, PTGS2, CXCL3, IL1F9, IL1B, TRM1, CXCL2, S100A9, CXCL1, IL6, EREG, VEGFA, CD163, and ADRB2.

12 . The method of claim 10 , comprising measuring the level of expression of at least eight of FN1, LIF, BDKRB1, TNFRSF11B, CFB, OLR1, CLEC7A, CXCL5, PTGS2, CXCL3, IL1F9, IL1B, TRM1, CXCL2, S100A9, CXCL1, IL6, EREG, VEGFA, CD163, and ADRB2.

13 . The method of claim 1 , wherein the subject has or is suspected of having diabetes, and the method comprises measuring the level of expression of at least three of CD163, PTGS2, TNFRSF11B, VEGFA, FN1, IL6, BDKRB1, S100A9, CXCL1, CXCL3, CFB, CLEC7A, IL1B, IL1F9, CXCL5, OLR1, LIF, CXCL2, TREM1, EREG, and ADRB2.

14 . The method of claim 13 , comprising measuring the level of expression of at least five of CD163, PTGS2, TNFRSF11B, VEGFA, FN1, IL6, BDKRB1, S100A9, CXCL1, CXCL3, CFB, CLEC7A, IL1B, IL1F9, CXCL5, OLR1, LIF, CXCL2, TREM1, EREG, and ADRB2.

15 . The method of claim 13 , comprising measuring the level of expression of at least eight of CD163, PTGS2, TNFRSF11B, VEGFA, FN1, IL6, BDKRB1, S100A9, CXCL1, CXCL3, CFB, CLEC7A, IL1B, IL1F9, CXCL5, OLR1, LIF, CXCL2, TREM1, EREG, and ADRB2.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 1, 2021
From: SHEA, LONNIE D.; OAKES, ROBERT S.; MORRIS, AARON; HUGHES, KEVIN
To: THE REGENTS OF THE UNIVERSITY OF MICHIGAN
Reel/Frame 057982/0510 →
Continuity (2)
Provisional Application 62748366 · Oct 19, 2018
Related Publication 20210382050A1 · Dec 9, 2021
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