Transplantation medium
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Publication Number
US-11524035-B2
Publication Date
2022-12-13
Expiration Date
Abstract
The present invention, in which RPE cells are suspended in a medium pharmaceutically acceptable as an ocular irrigating/washing solution and containing a poloxamer, achieves improvement of the post-thawing survival rate of cryopreserved RPE cells, improvement of the photoreceptor cell protection effect by RPE cell transplanted immediately after thawing, and prevention of loss of RPE cells in various steps from thawing to transplantation.
Core Innovation
The invention relates to a pharmaceutical composition for transplantation that includes a thawed retinal pigment epithelial (RPE) cell and poloxamer 188. The thawed RPE cell is suspended in a poloxamer 188-containing medium that is pharmaceutically acceptable as an ocular irrigating/washing solution, including modified Hank's Balanced Salt Solution or an oxyglutathione-containing ocular irrigating/washing solution, with poloxamer 188 at 0.001% (w/v) to 0.1% (w/v).
The problem addressed is post-thaw RPE cell loss and reduced survival and recovery after thawing when preparing cryopreserved RPE for transplantation. The composition preserves thawed RPE cell survival and recovery during the post-thaw workflow, including handling that involves centrifugation, dilution, washing, and passage through a transplantation device.
The invention further addresses improved photoreceptor cell protection by using the poloxamer 188-containing transplantation medium with thawed RPE cells. The disclosed compositions and production approach support improved handling, transportation, streamlined protocols, and use within defined thaw-to-transplantation time windows.
Claims Coverage
The document includes two independent claims. They focus on suspending thawed RPE cells in a poloxamer 188-containing ocular irrigating/washing medium at 0.001% (w/v) to 0.1% (w/v), and they associate this with improved RPE survival and recovery and, in one dependent form, photoreceptor cell protection.
Thawed RPE suspended in poloxamer 188 ocular irrigating/washing medium
A pharmaceutical composition for transplantation comprising a thawed retinal pigment epithelial (RPE) cell and poloxamer 188, wherein the thawed RPE cell is suspended in a poloxamer 188-containing medium pharmaceutically acceptable as an ocular irrigating/washing solution.
Modified HBSS or oxyglutathione ocular irrigating/washing solution with defined poloxamer range
The medium is a modified Hank's Balanced Salt Solution or an oxyglutathione-containing ocular irrigating/washing solution and the concentration of poloxamer 188 in the medium is 0.001% (w/v) to 0.1% (w/v).
Producing an RPE cell-containing composition by suspending thawed RPE in poloxamer 188 ocular irrigating/washing medium
A method for producing a retinal pigment epithelial (RPE) cell-containing composition, comprising suspending a thawed RPE cell in a poloxamer 188-containing medium pharmaceutically acceptable as an ocular irrigating/washing solution, wherein the medium is a modified Hank's Balanced Salt Solution or an oxyglutathione-containing ocular irrigating/washing solution and the concentration of the poloxamer 188 in the medium is 0.001% (w/v) to 0.1% (w/v).
The core inventive concept is the inclusion of poloxamer 188 in an ocular irrigating/washing solution to suspend thawed RPE cells at 0.001% (w/v) to 0.1% (w/v), with dependent claim forms asserting improved survival and recovery compared with compositions without poloxamer 188 and narrowing use to protection of a photoreceptor cell.
Stated Advantages
Improved survival rate of the thawed RPE cell compared to that without containing poloxamer 188.
Improved recovery rate of the thawed RPE cell compared to that without containing poloxamer 188.
Protection of a photoreceptor cell.
Documented Applications
Transplantation of thawed retinal pigment epithelial (RPE) cells into a subject using a poloxamer 188-containing ocular irrigating/washing solution.
Protection of photoreceptor cells in the context of RPE transplantation.
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