Abstract
Background: In 2003 the Blood Transfusion Center, Cliniques Universitaires Mont Godinne, Yvoir, Belgium implemented routine use of pathogen inactivation photochemical treatment (PCT) of platelet (PLT) components (INTERCEPT™ Blood System, Cerus Europe, Leusden, The Netherlands) for transfusion support of thrombocytopenia. Based on in vitro clonal T cell proliferation assays (> 5 log T cell inactivation), biochemical assays (1 adduct every 83 base pairs), animal studies (prevention of GVHD in a parent to F-1 model), and clinical trial experience (
Methods: PLT were collected on the Amicus Cell Separator (Fenwal Blood Technologies, Nivelles, Belgium) with process leuko-reduction. PLT were suspended in Intersol (Fenwal) with a ratio to plasma of ∼ 65:35%. PLT containing 2.5 to 6.0 × 1011 plts in ∼ 300 mL were prepared with an integrated processing set using amotosalen (150 uM) and UVA (3 J/cm2) to inactivate pathogens and leukocytes. PCT PLT units were issued the day after collection and stored for up to 7 d. Hematopoietic stem cell transplant (HSCT) patients were selected as a high risk population for TA-GVHD, and monitored for evidence of TA-GVHD with an active hemovigilance program. TA-GVHD was diagnosed using established criteria (
Results: During 3 years, 756 patients received 7,538 PCT PLT transfusions and 76 patients with a spectrum of hematologic diseases (Table) were treated with HSCT (n = 93: 75 auto- and 18 allo-grafts) and were supported with PCT PLT. 15 patients received 2 auto grafts, and one received 3. All HSCT patients were deemed at risk for TA-GVHD due to immune suppressive and/or myelo-ablative therapy including TBI (n = 19). Auto graft patients (n = 59) received a median of 7 PCT PLT (range 2–94). Allo graft patients (n = 17) received a median of 11 PCT PLT (range 3 – 127). No patient developed evidence of TA-GVHD during the 3-year period.
Conclusions: PCT of PLT prevented TA-GVHD in a population of HSCT patients at risk for TA-GVHD exposed to multiple platelet transfusions. Use of PCT to treat all PLT components avoided the need to identify at risk patients and permitted the use of a single PLT inventory. These clinical data support the use of PCT for replacement of gamma irradiation to prevent TA-GVHD.
Diagnosis/Year . | 2003 . | 2004 . | 2005 . | 2006 . | Total . | % . |
---|---|---|---|---|---|---|
Myeloma | 2 | 7 | 9 | 7 | 25 | 32.9 |
NH Lymphoma | 2 | 6 | 8 | 7 | 23 | 30.2 |
Acute Leukemia | 2 | 2 | 4 | 4 | 12 | 15.8 |
Hodgkins | 0 | 3 | 1 | 0 | 4 | 5.3 |
Myelofibrosis | 0 | 3 | 0 | 1 | 4 | 5.3 |
Myelodysplasia | 0 | 1 | 0 | 1 | 2 | 5.3 |
Solid Tumor | 0 | 1 | 1 | 0 | 2 | 2.6 |
CLL | 0 | 1 | 1 | 0 | 2 | 2.6 |
CML | 0 | 1 | 0 | 0 | 1 | 1.3 |
Waldenstrom’s | 0 | 1 | 0 | 0 | 1 | 1.3 |
Diagnosis/Year . | 2003 . | 2004 . | 2005 . | 2006 . | Total . | % . |
---|---|---|---|---|---|---|
Myeloma | 2 | 7 | 9 | 7 | 25 | 32.9 |
NH Lymphoma | 2 | 6 | 8 | 7 | 23 | 30.2 |
Acute Leukemia | 2 | 2 | 4 | 4 | 12 | 15.8 |
Hodgkins | 0 | 3 | 1 | 0 | 4 | 5.3 |
Myelofibrosis | 0 | 3 | 0 | 1 | 4 | 5.3 |
Myelodysplasia | 0 | 1 | 0 | 1 | 2 | 5.3 |
Solid Tumor | 0 | 1 | 1 | 0 | 2 | 2.6 |
CLL | 0 | 1 | 1 | 0 | 2 | 2.6 |
CML | 0 | 1 | 0 | 0 | 1 | 1.3 |
Waldenstrom’s | 0 | 1 | 0 | 0 | 1 | 1.3 |
Author notes
Disclosure:Employment: Laurence Corash is an employee of Cerus Corporation which provided research support for this study. Consultancy: Michele Jacquet and Jin Sying Lin are consultants paid by Cerus Corporation. Ownership Interests:; Laurence Corash is a beneficial owner of Cerus stock and stock options. Research Funding: Jean Claude Osselaer has received research funding from Cerus Corporation. Honoraria Information: Jean Claude Osselaer has recieved honoraria for service on advisory boards to Cerus Corporation. Membership Information: Jean Claude Osselaer has served on Cerus scientific advisory boards.
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