Cellular compositions derived from prior organ donors and methods of manufacture and use thereof
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10842821-B2
Publication Date
2020-11-24
Expiration Date
Abstract
The invention provides methods of making and using compositions for establishing mixed chimerism in a subject that include CD34+ cells and CD3+ cells derived from an apheresis product obtained from a subject that has previously donated a solid organ.
Core Innovation
The invention relates to cellular compositions and related methods to establish mixed chimerism in a recipient of a solid organ transplant from a donor. The approach uses donor-derived apheresis products comprising CD34+ cells and CD3+ cells, collected after the donor has donated the solid organ, and manufacturing a cellular product containing CD34+ cells and CD3+ cells from the collected apheresis product.
The manufacturing includes purification to enrich CD34+ cells while retaining CD3+ cells to produce a cellular product for establishing mixed chimerism. The enriched CD34+ portion can be mixed with a CD3+ portion, and alternatively the CD34+ portion and CD3+ portion can be handled as separate fractions in separate containers.
The document further describes that the donor-derived CD34+ cells and CD3+ cells can be used under HLA-matched or HLA-mismatched conditions for the solid organ transplant recipient. It also describes cryopreservation and containerization of the cellular product and subsequent administration to recipients after transplantation, with immunosuppression conditioning/withdrawal and monitoring to discontinue immunosuppressive therapy once mixed chimerism stabilizes.
Claims Coverage
The partial content identifies one independent claim, directed to a manufacturing method for producing a cellular product for establishing mixed chimerism using donor-derived apheresis products containing both CD34+ cells and CD3+ cells collected at a defined post-organ-donation time. The dependent claims refine manufacturing by CD34+ enrichment with CD3+ retention and optionally by mixing or separate handling, and further add HLA-matching/mismatching and time constraints for apheresis collection.
Post-organ-donation apheresis for mixed chimerism cellular product
Receiving at least one apheresis product comprising CD34+ cells and CD3+ cells obtained from a donor at least one day after the donor has donated the solid organ; and manufacturing the cellular product comprising CD34+ cells and CD3+ cells from the apheresis product.
CD34+ enrichment with CD3+ retention
Purifying to enrich CD34+ cells while retaining CD3+ cells as part of manufacturing the cellular product comprising CD34+ cells and CD3+ cells.
Mixing enriched CD34+ cells with retained CD3+ portion
Mixing an enriched amount of CD34+ cells with a second portion containing CD3+ cells.
HLA-matched CD34+ and CD3+ cells
Using HLA-matched CD34+ cells and CD3+ cells for a solid organ transplant recipient.
HLA-mismatched CD34+ and CD3+ cells
Using HLA-mismatched CD34+ cells and CD3+ cells for a solid organ transplant recipient.
Delayed apheresis collection threshold
Receiving at least one apheresis product collected from a donor at least four weeks after the donor has donated the solid organ.
Across the identified independent claim and refinements in the cited dependents, the claim coverage centers on manufacturing a mixed-chimerism cellular product from donor apheresis collected at least one day, or at least four weeks in a refinement, after solid organ donation, using CD34+ and CD3+ together, with optional CD34+ enrichment and retention of CD3+, and optional HLA-matched or HLA-mismatched usage.
Stated Advantages
Documented Applications
No documented applications found
Interested in licensing this patent?