Methods of delivery of islet cells and related methods
AssigneeSana Biotechnology, Inc.
InventorJohn Michael RUKSTALIS
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Abstract
Provided herein are methods related to delivery of stem cell-derived cell therapies, including stem cell derived islet cell therapies, and related compositions, uses and articles of manufacture. In particular embodiments, the methods relate administering stem cell-derived islet cells. In some embodiments, the subject has a beta cell related disorder, such as diabetes (e.g. Type I diabetes).
Claims95
A method of delivering a cell therapy to a subject, the method comprising administering to the subject a single cell suspension of stem cell-derived cells (SC-derived cells) capable of forming aggregated clusters of the SC-derived cells.
A method of delivering a cell therapy to a subject, the method comprising administering to the subject a population of stem cell-derived cells (SC-derived cells) capable of forming aggregated clusters of the SC-derived cells, wherein the population of SC-derived cells are administered intramuscularly without a bio-scaffold.
The method of any of claim 11, claims 12 and 17-19, wherein less than about 60%, less than about 50%, less than about 40%, less than about 30%, less than about 20%, less than about 10% or less than about 5% of cells of the single cell suspension are aggregated clusters of the SC-derived cells.
A method of delivering stem cell derived islet cells (SC-islet cells) to a subject, the method comprising administering to the subject a cell suspension of SC-islet cells, wherein the cell suspension of SC-islet cells comprise greater than 80% mature endocrine cells.
A method of delivering a stem cell derived islet cell (SC-islet cell) to a subject, the method comprising:
- (i) culturing pluripotent stem cells (PSCs) under conditions sufficient for differentiation of the PSCs into SC-islet cells, wherein the culturing does not include a step of aggregating the cells to form clusters;
- (ii) collecting the SC-islets into the single cell suspension comprising the SC-islet cells;
- and
- (iii) administering to the subject the single cell suspension comprising SC-islet cells.
A method of delivering a stem cell derived islet cell (SC-islet cell) to a subject, the method comprising:
- (i) culturing pluripotent stem cells (PSCs) under conditions sufficient for differentiation of the PSC into clusters of SC-islet cell;
- (ii) dissociating the clusters into a cell suspension comprising the SC-islet cells;
- and
- (iii) administering to the subject the cell suspension comprising SC-islet cells.
A method of delivering a stem cell derived islet cell (SC-islet cell) to a subject, the method comprising:
- (i) culturing a pluripotent stem cell (PSC) under conditions sufficient for differentiation of the PSC into first clusters of SC-islet cells;
- (ii) dissociating the first clusters into a first cell suspension comprising the SC-islet cells;
- (iii) aggregating the first cell suspension into second clusters of the SC-islet cells;
- (iv) dissociating the second clusters into a second cell suspension comprising the SC-islet cells;
- (iii) administering to the subject the second cell suspension comprising SC-islet cells.
A method of preparing a cell suspension of stem cell derived islet cells (SC-islet cells) for delivery to a subject, the method comprising:
- (i) culturing pluripotent stem cells (PSCs) under conditions sufficient for differentiation of the PSCs into SC-islet cells;
- (ii) collecting the SC-islet cells into a cell suspension comprising SC-islet cells;
- and
- (iii) cryopreserving the cell suspension,
- wherein the culturing does not include a step of aggregating the cells to form clusters.
A method of preparing a cell suspension of stem cell derived islet cells (SC-islet cells) for delivery to a subject, the method comprising:
- (i) culturing pluripotent stem cells (PSCs) under conditions sufficient for differentiation of the PSCs into clusters of SC-islet cells;
- (ii) dissociating the clusters into a cell suspension comprising SC-islet cells;
- and
- (iii) cryopreserving the single cell suspension.
A method of preparing a cell suspension of stem cell derived islet cells (SC-islet cells), the method comprising:
- (i) culturing pluripotent stem cells (PSCs) under conditions sufficient for differentiation of the PSCs into SC-islet cells;
- (ii) collecting the SC-islets into a first cell suspension comprising SC-islet cells;
- (iii) aggregating the first cell suspension into clusters of the SC-islet cells;
- (iv) dissociating the clusters into a second cell suspension comprising SC-islet cells;
- and
- (v) cryopreserving the second cell suspension.
A method of preparing a cell suspension of stem cell derived islet cells (SC-islet cells), the method comprising:
- (i) culturing pluripotent stem cells (PSCs) under conditions sufficient for differentiation of the PSCs into first clusters of SC-islet cells;
- (ii) dissociating the first clusters into a first cell suspension comprising SC-islet cells;
- (iii) aggregating the first cell suspension into second clusters of the SC-islet cells;
- (iv) dissociating the second clusters into a second cell suspension comprising SC-islet cells;
- and
- (v) cryopreserving the second cell suspension.
A cryopreserved composition comprising a cell suspension of stem cell-derived cells (SC-derived cells) capable of forming aggregated clusters of the SC-derived cells, wherein the cells are present in the composition at a density from 1×106 cells/mL to about 1×109 cells/mL.
Dependencies are inferred from the claim text.