Patent application EP19170975A (EP), filed 2019-04-25
Publication number: EP3730627A1
Title: METHOD FOR DONOR IDENTITY VERIFICATION
Abstract: A method for verification of donor identity in a mixed lymphocyte reaction product comprising cell material from a donor and a recipient, the method comprising (i) providing a mixed lymphocyte reaction (MLR) product comprising cell material from a donor and cell material from a recipient; (ii) subjecting the MLR product to DNase treatment; (iii) subjecting the DNase treated MLR product to DNA profiling and (iv) comparing the DNA profile of the DNase treated MLR product to a reference DNA profile of the donor to confirm or reject that the donor in the mixed lymphocyte reaction is the same as the donor of the reference profile.
IPC codes: C12N  15/    10            A I
C12Q   1/  6806            A I
Claims: number: 1
text: A method for verification of donor identity in a mixed lymphocyte reaction product comprising cell material from a donor and a recipient, the method comprising:
number: 2
text: A method according to claim 1, wherein the mixed lymphocyte reaction product provided in step i is the product of a one-way mixed lymphocyte reaction.
number: 3
text: A method according to claim 1 or 2, wherein the cell material from the recipient comprises non-proliferative T-cells.
number: 4
text: A method according to claims 1-3, wherein the cell material from the donor comprises peripheral mononuclear blood cells.
number: 5
text: A method according to claims 1-4, wherein the donor and the recipient are haplo-identical.
number: 6
text: A method according to claims 1-5, wherein the mixed lymphocyte reaction product which is provided in step i is a mixed lymphocyte reaction product wherein the alloreactive donor T cells have been inactivated or destroyed.
number: 7
text: A method according to claims 1-6, wherein the mixed lymphocyte reaction product provided in step i was frozen and thawed before being subjected to DNase treatment.
number: 8
text: A method according to claims 1-7, wherein proteinase and RNase free DNase is used.
number: 9
text: A method according to claims 1-8, wherein the DNA profiling is short tandem repeat (STR) profiling.
number: 10
text: A method according to claims 1-9, wherein the DNA is genomic DNA.
number: 11
text: A method according to claims 1-10, wherein the DNA profiling is performed using 5-30 loci
number: 12
text: A method according to claims 1-11, wherein the recipient has obtained or will obtain stem cell transplantation.
number: 13
text: A method according to claim 12, wherein the stem cell transplantation is T cell depleted CD34+ stem cell transplantation.
number: 14
text: A DNase treated mixed lymphocyte reaction product for verification of donor identity.
number: 15
text: The use of a DNase treated mixed lymphocyte reaction product according to claim 14 for verification of donor identity in a manufacturing process of a cell therapy product.
Office action: search_report, dated 2020-10-28
Rejection reasons: novelty_epc_54
inventive_step_epc_56
Prior art cited: ref_id: JP2003180662A
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ref_type: npl
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severity: background
ref_id: WO2017176985A1
ref_type: patent
severity: background
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ref_type: patent
severity: background
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severity: obviousness
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severity: novelty_destroying
Final disposition: pending (2020-10-28)