2018
|
|

Abstract: BACKGROUND Nucleic acid–targeted pathogen inactivation technology using amustaline (S‐303) and glutathione (GSH) was developed to reduce the risk of transfusion‐transmitted infectious disease and transfusion‐associated graft‐versus‐host disease with red blood cell (RBC) transfusion. STUDY DESIGN AND METHODS A randomized, double‐blind, controlled study was performed to assess the in vitro characteristics of amustaline‐treated RBCs (test) compared with conventional (control) RBCs and to evaluate safety and effic… Show more

Help me understand this report

Search citation statements

Order By: Relevance
Select...
1
1
1
1
0
25
1

Year Published

2018
2018
2019
2019

Publication Types

Select...
3

Relationship

1
2

Authors

Journals

0
25
1
Order By: Relevance
“…Pathogen reduction was performed in a functionally closed system of plastic containers within 24 h of collection using final concentrations of Amustaline (0·2 mmol/L) and Glutathione (20 mmol/L) as described. (Cancelas et al , ; Brixner et al , ) Process validation studies of Test RBCC at each production site were conducted prior to initiating clinical transfusions. Post‐production and quality control studies were performed on a subset of Test RBCC on day 35 of storage (Erickson et al , ).…”
Section: Methodsmentioning
“…The RBC were transfused after a mean storage interval of 18Á9 days. No antibodies to S-303 RBC were detected (Brixner et al, 2018). An in vitro study on Mirasol RBC and an RCT enrolling exclusively paediatric onco-haematology patients were performed by Trakhtman et al (2019).…”
Section: Autologous Transfusion Studies In Healthy Subjects and Clinimentioning
“…The RBC were transfused after a mean storage interval of 18·9 days. No antibodies to S‐303 RBC were detected (Brixner et al , ).…”
Section: Plateletsmentioning
“…The second‐generation system has undergone extensive evaluation and will be submitted for a European Conformity mark. The system has met FDA criteria for recovery and survival in humans, and met study endpoints in a clinical trial in a surgical patient population in Germany . Despite these encouraging observations, concerns still exist regarding alloantibody formation due to possible RBC alterations caused by the treatment.…”
Section: Literature Review Of Ta‐gvhd Casesmentioning
“…The system has met FDA criteria 93,94 for recovery and survival in humans, and met study endpoints in a clinical trial in a surgical patient population in Germany. 95 Despite these encouraging observations, concerns still exist regarding alloantibody formation due to possible RBC alterations caused by the treatment. Thus, a recently completed clinical trial using the second-generation S-303 system in 80 thalassemia patients in Turkey and Italy had, as a primary endpoint, the monitoring of RBC immunogenicity after multiple transfusions as per local practices.…”
Section: Remaining Concerns About Immunogenicity Of Pitreated Rbcsmentioning