Il sistema Mirasol, l‘esperienza di un centro italiano
Dott.ssa Paola Isernia
1
The Mirasol PRT System – Overview
+
Blood product
+
Riboflavin
(vitamin B2)
solution
UV Light
 Reduction of viruses, bacteria, parasites
 Inactivation of residual leucocytes
Mirasol System is Safe for Patients and Staff
• 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 staff
3
Riboflavin: the ideal sensitizer
O
CH3
N
CH3
N
NH
N
O
HO
HO
OH
OH
Riboflavin (vitamin B2)
Essential nutrient,
Recommended daily allowance 1.7 mg
Toxicology, Mutagenicity (GRAS, USA FDA)
GRAS= Genreally Regardes As Safe
PN 306690-190 ©2009 CaridianBCT
Mirasol System Process for Platelets and Plasma
Platelets
Transfuse or store for
up to five days
Connect and transfer
product to illumination
bag
Add riboflavin
solution
Illuminate
4 to10
minutes
Same simple process for
platelets and plasma
Plasma
Transfuse or
store frozen
for up to
two years
Connect and transfer
product to
illumination bag
Add riboflavin
solution
Illuminate
4 to10 minutes
Transfer to
storage bag
5
Broadly Effective Against Pathogens
Effectiveness Demonstrated Against Broad Range of Clinically
Relevant Pathogens
Pathogen type
Typical
Performance
Viruses
~2–6 log
(enveloped, non-enveloped;
intracellular, extracellular)
Parasites
(99.0–99.9999%)
> 3.0 to > 5.0
(Malaria, Chagas, Babesiosis,
Leishmaniasis..)
(>99.9% to >99.999%)
Bacteria
~2–5 log
(Gram +, Gram -)
(99.0-99.999%)
References
Ruane et al. 2004; Goodrich et al. 2006a;
Goodrich et al. 2006b
Cardo et al. 2006; Sullivan et al. 2008;
Cardo et al. 2007; Tonnetti et al. 2007;
Rentas et al. 2007
Ruane et al. 2004; Goodrich et al. 2006b
• Closing of window period for tested pathogens (known viruses)
• Added protection against untested pathogens (parasites, emerging pathogens)
• More effective than bacterial culture methods in use today (Goodrich et al. 2009)
6
Effective 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
7
Operational Flexibility and Efficiency
Efficient process
•
•
•
•
•
<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
Flexibility – A single system for all your platelet and plasma products
• Platelets in PAS or in plasma, from apheresis or whole blood
• Plasma (FFP), from apheresis or whole blood
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
9
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)
10
The Pavia experience
• Platelet product characteristics
–
–
–
–
Collection platform: Trima
Target dose: 3.6 x 1011; 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 : ?
 Number of patients treated : 36
Interim observation
• Ease of use
– Uncomplicated training of technicians
– Rapid process
– Easy integration to routine process
• Safe for operators
• Flexible: applicable to a broad range of products
Thank you !
QUESTIONS?