Method for treating diabetes and other glucose regulation disorders using stem cells

Inventors

Imran, Mir

Assignees

Incube Laboratories LLC

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Publication Number

US-12115195-B2

Patent

Publication Date

2024-10-15

Expiration Date


Abstract

Various embodiments of the invention provide methods of treating diabetes and other glucose regulation disorders. In one embodiment, the method comprises removing L-cells from a donor, obtaining stem cells from a patient, and culturing the L-cells in the presence of the stem cells under conditions such that the stem cells differentiate into stem cell-derived L-cells (SCDLC). An amount of the SCDLC is introduced into the patient sufficient to cause a lowering of the patient's blood glucose level after ingestion of food. In another embodiment, the method comprises removing K-cells from a donor, obtaining stem cells from a patient, and culturing the K-cells in the presence of the stem cells under conditions such that the stem cells differentiate into stem cell-derived K-cells (SCDKC). An amount of the SCDKC is introduced into the patient sufficient to cause a lowering of the patient's blood glucose level after ingestion of food.

Core Innovation

The invention provides a method for treating diabetes and other glucose regulation disorders by using donor L-cells and donor K-cells combined with patient-derived stem cells to generate stem cell-derived L-cells (SCDLC) and stem cell-derived K-cells (SCDKC). The method obtains L-cells from a donor and stem cells from a patient, then cultures the L-cells in the presence of a first portion of the stem cells under conditions such that the first portion differentiates into SCDLC. In parallel, the method obtains K-cells from the donor and cultures the K-cells in the presence of a second portion of the stem cells under conditions such that the second portion differentiates into SCDKC.

After generating SCDLC and SCDKC, the invention introduces an amount of the SCDLC and SCDKC into the patient. In one aspect, the introduced amount is sufficient to cause a lowering of the patient’s blood glucose level after the ingestion of food. In another aspect, the introduced amount is sufficient to maintain the patient’s blood glucose levels within euglycemic levels for an extended period.

The described approach is framed as reseeding and secretion of incretins after meals by using SCDLC and/or SCDKC in the patient, including after ingestion of food that includes carbohydrate and/or fat. The text further describes that differentiation monitoring can involve loss of pluripotency, multipotent, or oligopotent markers and/or appearance of L- or K-cell markers, and that functional selection can be based on minimum GLP-1 and/or GIP production.

Claims Coverage

The partial claims include two independent claims with four inventive features: one method claim for post-meal blood glucose lowering and one method claim for extended euglycemic maintenance. The claims are supported by dependent claims that add glucose-timing thresholds, diabetes subtype limitations, food constraints, and marker or exclusion constraints for the SCDLC/SCDKC compositions.

Culturing donor L-cells with patient stem cells to generate SCDLC

Obtain L-cells from a donor; obtain stem cells from a patient; culture the L-cells in the presence of a first portion of the stem cells under conditions such that the first portion differentiates into stem cell-derived L-cells (SCDLC).

Culturing donor K-cells with patient stem cells to generate SCDKC

Obtain K-cells from the donor; culture the K-cells in the presence of a second portion of the stem cells under conditions such that the second portion differentiates into stem cell-derived K-cells (SCDKC).

Administering SCDLC and SCDKC for post-meal blood glucose lowering

Introduce an amount of the SCDLC and SCDKC into the patient sufficient to cause a lowering of the patient’s blood glucose level after the ingestion of food.

Administering SCDLC and SCDKC for extended euglycemic maintenance

Introduce an amount of the SCDLC and SCDKC into the patient sufficient to maintain the patient’s blood glucose levels within euglycemic levels for an extended period.

Across the independent claims, the core coverage lies in separately culturing donor L-cells and donor K-cells with portions of patient-derived stem cells to generate SCDLC and SCDKC, then introducing a combined amount of the SCDLC and SCDKC to achieve either post-meal blood glucose lowering or extended maintenance of euglycemic blood glucose levels.

Stated Advantages

Lowering the patient’s blood glucose level after the ingestion of food.

Maintaining the patient’s blood glucose levels within euglycemic levels for an extended period.

Documented Applications

Treating diabetes.

Treating other glucose regulation disorders.

Treating Type I diabetes.

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