Cellular compositions derived from prior organ donors and methods of manufacture and use thereof
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.
1. A method for manufacturing a cellular product for establishing mixed chimerism in a recipient of a solid organ transplant from a donor, the method comprising:
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.
2. The method according to claim 1 , wherein manufacturing comprises:
purifying a first portion of the at least one apheresis product to obtain an enriched amount of CD34 + cells; and
retaining a second portion of the sample comprising CD3 + cells, thereby manufacturing the cellular product.
3. The method of claim 2 , further comprising: mixing the enriched amount of CD34 + cells with the second portion of the sample comprising CD3 + cells.
4. The method of claim 2 , further comprising: maintaining the enriched amount of CD34 + cells and the second portion of the sample comprising CD3 + cells in separate containers.
5. The method of claim 1 , wherein the CD34 + cells and the CD3 + cells are HLA-matched to the solid organ transplant recipient.
6. The method of claim 1 , wherein the CD34 + cells and the CD3 + cells are HLA-mismatched to the solid organ transplant recipient.
7. The method of claim 1 , wherein the at least one apheresis product is obtained from a donor at least four weeks after the donor has donated the solid organ.
8. The method of claim 7 , wherein the at least one apheresis product is obtained from a donor at least one year after the donor has donated the solid organ.
9. The method of claim 1 , further comprising:
obtaining the at least one apheresis product from the donor after the donor has donated the solid organ.