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 LightBlood product

+

The Mirasol PRT System – Overview

+

• Riboflavin and its photoproducts are naturally present in normalblood, 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 removalof riboflavin or its photo-products

No contra-indications for patients No special precautions for staff

Mirasol System is Safe for Patients and Staff

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PN 306690-190 ©2009 CaridianBCT

Riboflavin (vitamin B2)Essential nutrient,

Recommended daily allowance 1.7 mgToxicology, Mutagenicity (GRAS, USA FDA)

Riboflavin: the ideal sensitizer

OH

OHOH

OH

CH3

CH3

O

ON

NHN

N

GRAS= Genreally Regardes As Safe

Mirasol System Process for Platelets and Plasma

Connect and transfer product to illumination

bag

Add riboflavin solution

Illuminate4 to10

minutes

Transfuse or store for up to five days

Plat

elet

s

Connect and transfer product to

illumination bag

Add riboflavin solution

Illuminate 4 to10 minutes

Transfer to storage bag

Transfuse or store frozen

for up totwo yearsPl

asm

a

Same simple process for platelets and plasma

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Broadly Effective Against Pathogens

Pathogen type TypicalPerformance 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

Effectiveness 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 effective than bacterial culture methods in use today (Goodrich et al. 2009)

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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

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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 StudyPlatelets 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 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

QUESTIONS?

Thank you !