PREPARATION AND USE OF PLATELET PRODUCTS
The present disclosure relates to improved methods for the preparation and platelet products for administration to subjects in need thereof
1 . A method of providing a platelet product to a subject in need thereof, comprising administering to a human subject with elevated risk for a leukocyte-related transfusion complication a platelet product,
wherein the platelet product comprises one or more whole blood-derived platelet components prepared from whole blood donation(s);
wherein the platelet product has been subjected to photochemical treatment with a psoralen compound to inactivate pathogens and leukocytes, if present; and
wherein the platelet product has not been subjected to treatment with either ionizing irradiation or a filtration medium to reduce the level of contaminating leukocytes.
2 . The method of claim 1 , wherein the one or more platelet components are prepared from whole blood donation(s) by a buffy coat method, or wherein the one or more platelet components are prepared from whole blood donation(s) by a platelet rich plasma (PRP) method.
3 . (canceled)
4 . The method of claim 1 , wherein the platelet product is a pooled platelet product, comprising a mixture of at least two platelet components.
5 . (canceled)
6 . The method of claim 1 , wherein the platelet product comprises about 2.0×10 11 to about 8.0×10 11 platelets.
7 - 10 . (canceled)
11 . The method of claim 1 , wherein the platelet product has not been subjected to treatment with a leukocyte reduction filter.
12 . The method of claim 1 , wherein the platelet product is a transfusion ready platelet product.
13 . The method of claim 1 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a recipient of peripheral blood stem cell or bone marrow transplant.
14 . The method of claim 1 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a recipient of ablative chemotherapy and/or radiotherapy.
15 . The method of claim 1 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a subject diagnosed with a hematologic malignancy or solid tumor.
16 . The method of claim 1 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a subject diagnosed with an immunodeficiency.
17 - 19 . (canceled)
20 . The method of claim 1 , wherein administering the platelet product to the subject results in a 1 hour corrected count increment (CCI) of greater than 5,000.
21 . The method of claim 4 , wherein the method reduces a leukocyte-related transfusion complication.
22 . A method of preparing a transfusion ready platelet product for administration to a subject in need thereof, comprising:
a) preparing from whole blood donations a plurality of whole blood-derived platelet components;
b) pooling two or more of the platelet components to produce a pooled platelet product;
c) subjecting the pooled platelet product or each platelet component to photochemical treatment with a psoralen compound to inactivate pathogens and leukocytes, if present, comprising adding to the pooled platelet product or each platelet component the psoralen compound and exposing the mixture of pooled platelet product and psoralen compound or each platelet component and psoralen compound to ultraviolet A light; and
d) transferring the photochemical treated pooled platelet product to a storage container to provide a transfusion ready platelet product.
23 . The method of claim 22 , wherein the storage container comprises suitable labeling for human use.
24 . The method of claim 22 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a recipient of a peripheral blood stem cell or bone marrow transplant.
25 . The method of claim 22 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a recipient of ablative chemotherapy and/or radiotherapy.
26 . The method of claim 22 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a subject diagnosed with a hematologic malignancy or solid tumor.
27 . The method of claim 22 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a subject diagnosed with an immunodeficiency.
28 . The method of claim 22 , wherein the plurality of whole-blood derived platelet components is prepared from whole blood donations by a buffy coat method, or wherein the plurality of whole-blood derived platelet components is prepared from whole blood donations by a platelet rich plasma (PRP) method.
29 - 30 . (canceled)
31 . The method of claim 22 , wherein the transfusion ready platelet product comprises about 2.0×10 11 to about 8.0×10 11 platelets.
32 - 35 . (canceled)
36 . The method of claim 22 , wherein the transfusion ready platelet product has not been subjected to treatment with a leukocyte reduction filter.
37 . The method of claim 22 , wherein the transfusion ready platelet product has not been subjected to treatment with ionizing radiation.
38 . The method of claim 22 , wherein the storage container comprises labeling indicating that treatment with ionizing radiation or a leukocyte reduction filter is not required prior to administration of the platelet product to a subject.
39 . The method of claim 22 , wherein the storage container further comprises instructions indicating that treatment with ionizing radiation or a leukocyte reduction filter is not required prior to administration of the platelet product to a subject.
40 . The method of claim 22 , further comprising e) providing the transfusion ready platelet product for administration to a human subject in need thereof with elevated risk for a leukocyte-related transfusion complication, without a further step of treatment with either gamma irradiation or a filtration medium to reduce the level of contaminating leukocytes.
41 . The method of claim 22 , further comprising administering the transfusion ready platelet product to a subject in need thereof.
42 . A method of providing a platelet product to a subject in need thereof, comprising administering to a human subject a transfusion ready platelet product prepared according to claim 22 .
43 . The method of claim 41 , wherein the subject is a human subject with elevated risk for a leukocyte-related transfusion complication.
44 - 46 . (canceled)
47 . The method of claim 41 , wherein administering the transfusion ready platelet product to the subject results in a 1 hour corrected count increment (CCI) of greater than 5,000.
48 . The method of claim 7 , wherein the method reduces a leukocyte-related transfusion complication.
49 . A method for reducing leukocyte-related transfusion complications in a recipient of a platelet product, comprising:
a) preparing from whole blood donations a plurality of whole blood-derived platelet components;
b) pooling two or more platelet components to produce a pooled platelet concentrate;
c) subjecting the pooled platelet product or each platelet component to photochemical treatment with a psoralen compound to inactivate pathogens and leukocytes, if present, comprising adding to the pooled platelet product or each platelet component the psoralen compound and exposing the mixture of pooled platelet product and psoralen compound or platelet component and psoralen compound to ultraviolet light;
d) transferring the photochemical treated pooled platelet product to a storage container to provide a transfusion ready platelet product; and
e) administering the transfusion ready platelet product to a human subject in need thereof, without a further step of treatment with either gamma irradiation or a filtration medium to reduce the level of contaminating leukocytes.
50 . The method of claim 49 , wherein the storage container comprises suitable labeling for human use.
51 . The method of claim 49 , wherein the recipient is a human subject with elevated risk for a leukocyte-related transfusion complication.
52 . The method of claim 49 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a recipient of peripheral blood stem cell or bone marrow transplant.
53 . The method of claim 49 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a recipient of ablative chemotherapy and/or radiotherapy.
54 . The method of claim 49 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a subject diagnosed with a hematologic malignancy or solid tumor.
55 . The method of claim 49 , wherein the subject with elevated risk for a leukocyte-related transfusion complication is a subject diagnosed with an immunodeficiency.
56 . The method of claim 49 , wherein the plurality of platelet components is prepared by a buffy coat method, or wherein the plurality of platelet components is prepared by a PRP method.
57 - 58 . (canceled)
59 . The method of claim 49 , wherein the transfusion ready platelet product comprises about 2.0×10 11 to about 8.0×10 11 platelets.
60 - 63 . (canceled)
64 . The method of claim 49 , wherein the transfusion ready platelet product has not been subjected to treatment with a leukocyte reduction filter prior to administration to the subject.
65 . The method of claim 9 , wherein the transfusion ready platelet product has not been subjected to treatment with ionizing radiation.
66 . The method of claim 49 , wherein the storage container comprises labeling indicating that treatment with ionizing radiation or a leukocyte reduction filter is not required prior to administration of the platelet product to a subject.
67 . The method of claim 49 , wherein the storage container further comprises instructions indicating that treatment with ionizing radiation or a leukocyte reduction filter is not required prior to administration of the platelet product to a subject.
68 - 70 . (canceled)
71 . The method of claim 49 , wherein administering the transfusion ready platelet product to the subject results in a 1 hour corrected count increment (CCI) of greater than 5,000.
72 . A transfusion ready platelet product prepared by the method of claim 22 .
73 . A transfusion ready platelet product, comprising one or more whole blood-derived platelet components in a storage container with suitable labeling for human use, wherein the one or more platelet components have been subjected to photochemical treatment with a psoralen compound, and wherein the transfusion ready platelet product has not been subjected to treatment with ionizing radiation or a leukocyte reduction filter.
74 . The transfusion ready platelet product of claim 73 , wherein the storage container comprises labeling indicating that treatment with either ionizing radiation or a leukocyte reduction filter is not required for administration to a subject.
75 . The transfusion ready platelet product of claim 73 , wherein the one or more whole blood-derived platelet components are prepared by a buffy coat method, or wherein the one or more whole blood-derived platelet components are prepared by a platelet rich plasma (PRP) method.
76 - 77 . (canceled)
78 . The transfusion ready platelet product of claim 73 , wherein the transfusion ready platelet product comprises about 2.0×10 11 to about 8.0×10 11 platelets.
79 - 82 . (canceled)
83 . The transfusion ready platelet product of claim 73 , wherein the transfusion ready platelet product is a platelet product for use in treating a subject with elevated risk for a leukocyte-related transfusion complication.