Production of pathogen‐inactivated RBC concentrates using PEN110 chemistry: a Phase I clinical study

AuBuchon, James P.; Pickard, Constance; Herschel, Louise; Roger, J; Tracy, J. E.; Purmal, Andrei A.; Chapman, John; Ackerman, Samuel; Beach, Kathleen J.

doi:10.1046/j.1537-2995.2002.00021.x

Cited by 40 publications

(29 citation statements)

References 12 publications

(17 reference statements)

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“…The INACTINE process for preparation of pathogen‐reduced RBCs combines chemical inactivation of pathogenic microorganisms 11,12 with RBC purification 13,14 to improve the transfusion safety of RBCs 15‐20 . The process utilizes PEN110, a small, positively charged electrophilic molecule that is chemically related to binary ethyleneimine.…”

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confidence: 99%

Prevention of Yersinia enterocolitica, Pseudomonas fluorescens, and Pseudomonas putida outgrowth in deliberately inoculated blood by a novel pathogen‐reduction process

Zavizion¹,

Serebryanik²,

Serebryanik³

et al. 2003

Transfusion

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mentioning

confidence: 99%

Prevention of Yersinia enterocolitica, Pseudomonas fluorescens, and Pseudomonas putida outgrowth in deliberately inoculated blood by a novel pathogen‐reduction process

Zavizion¹,

Serebryanik²,

Serebryanik³

et al. 2003

Transfusion

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“…In addition to these preclinical studies, clinical studies will be required to evaluate the quality of RBCs prepared with this new technology. A Phase I study, based in part on the results of these studies, has been conducted 17 …”

Section: Discussionmentioning

confidence: 99%

Process for the preparation of pathogen‐inactivated RBC concentrates by using PEN110 chemistry: preclinical studies

et al. 2002

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“…) and survival (mean P 1 .05 33.5 ‫ע‬ 4.2 days vs. 28.5 ‫ע‬ 4.3 days; ) duration ‫ע‬ SD, P 1 .05 were not significantly different between the 2 groups [50]. A phase III clinical trial is now being developed.…”

Section: Rbcsmentioning

confidence: 98%

Progress Toward a Pathogen-Free Blood Supply

McCullough

2003

Clinical Infectious Diseases

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Although the nation's blood supply is safer than ever, a small risk of transfusion-transmitted infection remains. Present strategies to further reduce the risk, such as the donor medical evaluation or laboratory testing, will not likely eliminate this risk. A different approach involves treating donated blood to eliminate its infectivity. A pathogen-inactivated plasma product was available for several years but was recently withdrawn. Several other methods are under development, but all of these prevent nucleic acids from replicating, thus inactivating any contaminating viruses or bacteria. Toxicity, mutagenicity, and safety margins seem to be adequate, and damage to blood proteins or cellular elements is minimal. Clinical trials of pathogen-inactivated platelets have been completed in Europe and in the United States, and phase III clinical trials of pathogen-inactivated red blood cells are underway in the United States. If these encouraging results are sustained, the risk of transfusion-transmitted disease may be nearly eliminated.

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Production of pathogen‐inactivated RBC concentrates using PEN110 chemistry: a Phase I clinical study

Abstract: PEN110-treated RBCs stored for 28 days meet all critical requirements for therapeutically useful units.

Cited by 40 publications

References 12 publications

Prevention of Yersinia enterocolitica, Pseudomonas fluorescens, and Pseudomonas putida outgrowth in deliberately inoculated blood by a novel pathogen‐reduction process

Prevention of Yersinia enterocolitica, Pseudomonas fluorescens, and Pseudomonas putida outgrowth in deliberately inoculated blood by a novel pathogen‐reduction process

Process for the preparation of pathogen‐inactivated RBC concentrates by using PEN110 chemistry: preclinical studies

Progress Toward a Pathogen-Free Blood Supply

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