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Cerus reaches significant milestones in the development of INTERCEPT Red Blood Cells
The European Phase 3 clinical trial of red blood cells treated with the INTERCEPT Blood System for acute anemia in cardiovascular surgery patients met the primary endpoint. Preliminary analysis demonstrated that the mean hemoglobin content (53.1g) of INTERCEPT-treated red blood cell components (RBCs) on day 35 of storage met the protocol-defined criteria for equivalence based on the inferiority margin of 5g compared to conventional red blood cell components (55.8g). Furthermore US Phase 2 clinical trial of INTERCEPT Red Blood Cells met primary endpoint with a comparable RBC recovery (83%) when compared to control RBCs (85%); both INTERCEPT-treated and control red blood cells met the criteria for red blood cell recovery recommended by the U.S. Food and Drug Administration. Cerus plans to include these data in the filing for CE Mark approval anticipated in the second half of 2016.
» Read the Cerus Press Release on EU Phase 3 Clinical trial
» Read the Cerus Press Release on US Phase 2 Clinical trial |
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INTERCEPT Blood SystemTM Global Status |
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ASK THE EXPERT
Jean-Marc Payrat from Cerus BV
Director Development and Research
Q: What is the residual risk for bacterial contamination after early culture detection?
A: The rate of bacterial contamination after early bacterial culture detection in apheresis platelets has been estimated at 1:1500 to 1:2747; comparable risk has been reported for pre-storage pooled whole blood derived platelets. (Ref 1-5). When considering an average platelet dose of 6 units per patient, this translates to ~1:250 per patient risk. (Ref 6)
1. Dumont LJ et al. Transfusion 2010; 50:589.; 2. Pearce S et al. Transfus Med 2011; 21:25.; 3.Murphy WG et al. Vox Sang 2008; 95:13.; 4.Yomtovian, R, Jacobs, MR, Westra, J, et al., 2011, Transfusion, 51(s):197A.; 5. Benjamin, RJ, Kline, L, Dy, BA, et al., 2008, Transfusion, 48:2348-2355.; 6. Kleinman S, et al. Transfusion. 2013 53, 1603.
Q: What is the remaining bacterial risk in platelets after Pathogen Inactivation with INTERCEPT?
A: In France and Switzerland nearly 250,000 INTERCEPT platelets have been transfused without any reported transfusion transmitted infection caused by bacteria. In France during the same period 44 cases have been reported, including 8 fatalities, with conventional untreated platelets. In the “Haemovigilance Annual report 2013” published by Swissmedic authors mentioned “The reliable prevention of clinically relevant bacterial contamination of platelet concentrates, was clearly achieved by the countrywide implementation of the Intercept procedure for all platelet components in Switzerland.”
» Read the Swissmedic Haemovigilance Annual report 2013 (page 15)
Transfusion Transmitted Infections caused by bacterial contamination
 Q: Are all Pathogen Inactivation systems equally effective in reducing bacterial risk in platelets.
A: Kwon et all (ref. 7) compared the Pathogen inactivation efficacy of Mirasol PRT System and Intercept Blood System for non-leukoreduced platelet-rich plasma-derived platelets suspended in plasma. The authors concluded that “Inactivation efficacy of Intercept was more robust for all bacteria tested at high or low titres” and observed that “post-inactivation bacterial growth in platelets inoculated with a low titre of S. aureus or B. subtilis was detected only with Mirasol”.
7. Kwon et all, Vox Sang. 2014 Oct;107(3):254-60.
» Read the abstract |
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What we're reading |
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Pathogen inactivation of double-dose buffy-coat platelet concentrates photochemically treated with amotosalen and UVA light: preservation of in vitro function
P. Sandgren and B. Diedrich,
Vox Sang. 2014 Dec 30. doi: 10.1111/vox.12232.
» Read the abstract
Pathogen inactivation or pathogen reduction: proposal for standardization of nomenclature
Lozano, M., Cid, J., Prowse, C., McCullough, J., Klein, H. G. and Aubuchon, J. P. (2015),
Transfusion. doi: 10.1111/trf.12996
» Read the abstract
Evidence of meaningful levels of Trypanosoma cruzi in platelet concentrates from seropositive blood donors
Cancino-Faure, B., Fisa, R., Riera, C., Bula, I., Girona-Llobera, E. and Jimenez-Marco, T.
(2015), Transfusion. doi: 10.1111/trf.12989
» Read the abstract
Transfusion transmitted infections in solid organ transplantation.
Mezochow AK1, Henry R, Blumberg EA, Kotton CN.
Am J Transplant. 2015 Feb;15(2):547-54. doi: 10.1111/ajt.13006
» Read the abstract
Real-time symptomatic case of transfusion-transmitted dengue
José Eduardo Levi, Anna Nishiya, Alvina Clara Félix, Nanci Alves Salles,
Luciana Ribeiro Sampaio, Fátima Hangai, Ester Cerdeira Sabino and Alfredo Mendrone Jr
Transfusion. 2015 Jan 21. doi: 10.1111/trf.12944
» Read the abstract
Epidemiological, clinical, and laboratory characteristics of 48 cases of "Babesia venatorum" infection in China: a descriptive study.
Jiang JF, Zheng YC, Jiang RR, Li H, Huo QB, Jiang BG, Sun Y, Jia N, Wang YW, Ma L, Liu HB, Chu YL, Ni XB, Liu K, Song YD, Yao NN, Wang H, Sun T, Cao WC.
The Lancet Infectious diseases Volume 15, No. 2, p196–203, February 2015
» Read the abstract
Transfusion of Plasma, Platelets, and Red Blood Cells in a 1:1:1 vs a 1:1:2 Ratio and Mortality in Patients With Severe Trauma. The PROPPR Randomized Clinical Trial
John B. Holcomb; Barbara C. Tilley ; Sarah Baraniuk ; Erin E. Fox; Charles E. Wade, Jeanette M. Podbielski, Deborah J. del Junco, Karen J. Brasel; Eileen M. Bulger; Rachael A. Callcut; Mitchell Jay Cohen; Bryan A. Cotton; Timothy C. Fabian; Kenji Inaba; Jeffrey D. Kerby; Peter Muskat; Terence O’Keeffe; Sandro Rizoli; Bryce R. H. Robinson; Thomas M. Scalea; Martin A. Schreiber; Deborah M. Stein; Jordan A. Weinberg; Jeannie L. Callum; John R. Hess; Nena Matijevic; Christopher N. Mille; Jean-Francois Pittet; David B. Hoyt; Gail D. Pearson, ; Brian Leroux; Gerald van Belle; for the PROPPR Study Group
JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12
» Read the abstract |
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Calender of events |
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- Wiener Bluttage, April 9 – 11, Vienna, Austria
- SIdEM - Societa Italiano di Emaferesi & Manipolazione Cellulare, April 15 – 18, Bari, Italy
- SVTM - Swisstransfusion 2015, April 23 – 24, Lugano, Italy
- 25th Regional Congress of the ISBT, June 27 – July 1, London, United Kingdom
- AABB annual meeting, October 24 – 27, Anaheim, Unites States
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