# US 2026/0085291 A1 · Prevention and/or treatment of type 1 diabetes by augmentation of myeloid suppressor cell activity

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- Number: US 2026/0085291 A1
- Document ID: US20260085291A1
- Status: Published application
- Kind: A1
- Application number: 19/303,763
- Filed: 2025-08-19
- Published: 2026-03-26
- Earliest claimed: 2021-06-08
- Assignees: Creative Medical Technologies, Inc.
- Applicants: Creative Medical Technologies, Inc.
- Inventors: Thomas Ichim; Amit Patel
- Web page: https://patentgrep.com/patent/US20260085291A1

## CPC

- C12N 5/0662: {Stem cells}
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 40/10: characterised by the cell type used
- A61K 40/22: Immunosuppressive or immunotolerising
- A61K 40/416: {Antigens related to auto-immune diseases; Preparations to induce self-tolerance}
- A61L 27/3834: {Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells}
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- C12N 5/0634: {Cells from the blood or the immune system}
- A61K 2239/31: characterized by the route of administration
- A61K 2239/38: characterised by the dose, timing or administration schedule
- C12N 2501/12: Hepatocyte growth factor [HGF]
- C12N 2501/2302: Interleukin-2 (IL-2)
- C12N 2501/24: Interferons [IFN]
- C12N 2502/1352: Mesenchymal stem cells
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Disclosed are means, methods and compositions of matter useful for prevention and/or reversion of type 1 diabetes by upregulation of myeloid suppressor cell activity in a mammal suffering from and/or at risk of developing type 1 diabetes. In one embodiment the invention teaches administration of immune cells that have been conditioned by exposure to regenerative cells, and/or cultured in the presence of factors produced from regenerative cells. In one embodiment said regenerative cells are umbilical cord derived mesenchymal stem cells. In one embodiment, immune cells that have been exposed to said regenerative cells are administered together with agents known to enhance myeloid suppressor cell activity. In another embodiment immune cells are administered together with exogenous myeloid suppressor cells. 2

## Claims

### Claim 1

A method of treating type 1 diabetes comprising the steps of: a) selecting a patient suffering from type 1 diabetes; b) extracting an immune cell population comprising T regulatory cells from said patient; c) exposing said immune cell population to interleukin-2 (IL-2) and conditioned media from mesenchymal stem cells derived from a source selected from the group consisting of: placental tissue, amniotic membrane, umbilical cord tissue, fallopian tube tissue, and subepithelial umbilical cord tissue and treated with interferon gamma; d) separating T regulatory cells from said immune cell population and administering said T regulatory cells back into said patient in need of treatment; and e) administering an agent capable of enhancing the number and/or activity of myeloid suppressor cells selected from the group consisting of granulocyte-macrophage colony-stimulating factor (GM-CSF) and Bacillus Calmette-Guérin (BCG) vaccine into said patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein said separated T regulatory cells express FoxP3.

### Claim 3 (depends on 1)

The method of claim 1, wherein said separated T regulatory cells express membrane TGF-beta.

### Claim 4 (depends on 1)

The method of claim 1, wherein the conditioned media expresses at least 200 pg/ml of hepatocyte growth factor (HGF) after treatment with interferon gamma.

### Claim 5 (depends on 1)

The method of claim 1, wherein said immune cell population are splenocytes.

### Claim 6 (depends on 1)

The method of claim 1, wherein the T regulatory cells are administered to the patient intravenously.

### Claim 7 (depends on 1)

The method of claim 1, wherein said separated T regulatory cells express membrane TGF-beta and FoxP3.

### Claim 8 (depends on 1)

The method of claim 1, wherein said separated T regulatory cells express the following markers: CD4+, CD25+, and CD3+.

### Claim 9 (depends on 1)

The method of claim 1, wherein said separated T regulatory cells express the following markers: CD3+, CD28+, CD4+, CD8+, CD45RA+, and CD45RO+ T cells.

### Claim 10 (depends on 1)

The method of claim 1, wherein said separated T regulatory cells express the following markers: CD3+, and CD28+.

### Claim 11 (depends on 1)

The method of claim 1, wherein said separated T regulatory cells express the following markers: CD4+ and CD25+.

### Claim 12 (depends on 1)

The method of claim 1, wherein the mesenchymal stem cells express the following markers: CD73, CD90 and CD105 and do not express: CD14, CD45, and CD34.

### Claim 13 (depends on 1)

The method of claim 1, wherein the mesenchymal stem cells express the following markers: oxidized low density lipoprotein receptor 1 b, chemokine receptor ligand 3, and granulocyte chemotactic protein and do not express CD117, CD31, CD34, and CD45.

### Claim 14 (depends on 1)

The method of claim 1, wherein the mesenchymal stem cells express the following markers: CD10, CD13, C44, CD73, CD90, platelet-derived growth factor receptor-alpha (PDGFr-alpha), Programmed cell death ligand 2 (PD-L2), and human leukocyte antigens (HLA) selected from the group consisting of A, B, and C, or mixtures thereof, and do not express CD31, CD34, C45, CD80, CD86, CD117, CD141, CD178, B7-H2, HLA-G and HLA, selected from the group consisting of DR, DP, and DQ, or mixtures thereof.
