Il sistema Mirasol, l‘esperienza di un centro italiano
Dott.ssa Paola Isernia
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Reduction of viruses, bacteria, parasites
Inactivation of residual leucocytes
Riboflavin (vitamin B2)
solution
UV Light Blood product
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The Mirasol PRT System – Overview
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• Riboflavin and its photoproducts are naturally present in normal blood, no new compounds are formed
• Riboflavin and its photoproducts are non-toxic & non-mutagenic
• Extensive toxicology testing has shown no safety concerns
Mirasol does not require removal of riboflavin or its photo-products
No contra-indications for patients
No special precautions for staf
Mirasol System is Safe for Patients and Staf
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PN 306690-190 ©2009 CaridianBCT
Riboflavin (vitamin B2) Essential nutrient,
Recommended daily allowance 1.7 mg Toxicology, Mutagenicity (GRAS, USA FDA)
Riboflavin: the ideal sensitizer
OH O
H OH
O H CH3 CH3
O
O N
N NH N
GRAS= Genreally Regardes As Safe
Mirasol System Process for Platelets and Plasma
Connect and transfer product to illumination
bag
Add riboflavin
solution Illuminate
4 to10 minutes
Transfuse or store for up to five days
Platelets
Connect and transfer product to illumination bag
Add riboflavin solution
Illuminate 4 to10 minutes
Transfer to storage bag
Transfuse or store frozen
for up to two years
Plasma
Same simple process for platelets and plasma
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Broadly Efective Against Pathogens
Pathogen type Typical
Performance References
Viruses
(enveloped, non-enveloped;
intracellular, extracellular)
~2–6 log
(99.0–99.9999%)
Ruane et al. 2004; Goodrich et al. 2006a;
Goodrich et al. 2006b
Parasites
(Malaria, Chagas, Babesiosis, Leishmaniasis..)
> 3.0 to > 5.0
(>99.9% to >99.999%)
Cardo et al. 2006; Sullivan et al. 2008;
Cardo et al. 2007; Tonnetti et al. 2007;
Rentas et al. 2007 Bacteria
(Gram +, Gram -)
~2–5 log
(99.0-99.999%) Ruane et al. 2004; Goodrich et al. 2006b
Efectiveness Demonstrated Against Broad Range of Clinically Relevant Pathogens
• Closing of window period for tested pathogens (known viruses)
• Added protection against untested pathogens (parasites, emerging pathogens)
• More efective than bacterial culture methods in use today (Goodrich et al. 2009) 6
Efective Inactivation of White Blood Cells
Reducing Immunological Complications of Transfusion
White Blood Cell (WBC)
Inactivation Study Study Type Performance Reference
WBC inactivation In vitro ≥ 6 log
(99.9999%) Fast et al. 2006a Cytokine production and expression In vitro prevented Fast et al. 2006a
Graft-versus-Host Disease In vivo animal
study prevented Fast et al. 2006b
Alloimmunization and transplant
rejection In vivo animal
study prevented Asano et al. 2007
• Mirasol system may be used as alternative to Gamma-irradiation for the prevention of transfusion-associated Graft-versus-Host Disease (approved claim)
• Mirasol system may reduce other immunological complications caused by contaminating WBCs; additional studies are in progress to evaluate this
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Operational Flexibility and Efficiency
• Platelets in PAS or in plasma, from apheresis or whole blood
• Plasma (FFP), from apheresis or whole blood
Flexibility – A single system for all your platelet and plasma products
• <15 minutes total process time
• <5 minutes hands-on time
• Broad treatment ranges
• Minimal product loss (1–2%)
• No removal step required, immediate product release
• Comprehensive data reporting and traceability
Efficient process
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The Hemovigilance (HV) Program
So far:
• 16,213 transfusions of Mirasol-treated platelet concentrates (PC) have been reported to our HV- program
• 32,165 transfusions of Mirasol-treated FFP have been reported
Fifty-nine adverse events were reported after transfusion of PC and 10 after transfusion of FFP.
No adverse events related to the medical device.
Participation of centers is on voluntary basis. The current list of participants under routine use is:
• One site each in Poland, Serbia, Greece, Lithuania , Luxemburg and 2 sites in Italy
• The program includes transfusion data from MIRACLE, CAP and MEP studies
Currently, a bi-monthly questionnaire is sent to the sites
A databank is being developed to be located at our sharepoint address.
It will enable customers in the future to update their own data by themselves with permission by user ID and password
IPTAS Study
IPTAS = Italian Platelet Technology Assessment Study Platelets in PAS
• Conducted by IPTAS Study Group in Italy
• Primary endpoint: Patients with ≥ Grade 2 bleeding
• A total of 828 subjects targeted at 6 sites, 3 Mirasol (Pavia, Roma and Genova) and 3 Intercept (Verona, Milan, TBD)
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The Pavia experience
• Platelet product characteristics
– Collection platform: Trima
– Target dose: 3.6 x 10
11; Average volume: 270mL – Percent Plasma: 33%
– PAS: SSP+ (added manually after Trima collection)
• Software integration
Implementation in routine
•
Mirasol procedures :
Implementation: October 28, 2010
Test/Validation phase : X procedures in (when?)
Routine implementation in November 2010
Procedures to date : ?
