Volume 13, Issue 11 (3-2015)                   JRUMS 2015, 13(11): 1091-1096 | Back to browse issues page

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Jafar-Gholizadeh S, Nasiri S, Mirabzadeh Ardakani E, Seyfkordi A. Evaluation of Toxicity Test on Infusible Platelet Membrane in Mice: A Short Report . JRUMS. 2015; 13 (11) :1091-1096
URL: http://journal.rums.ac.ir/article-1-2258-en.html
Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
Abstract:   (4658 Views)

Background and Objective: Blood platelet units are generally stored in blood banks for 3–5 days, afterwards they are discarded. Prepared infusible platelet membrane (IPM) from fresh or outdated human platelets correct the prolonged bleeding times in thrombocytopenic animals such as rabbits. Abnormal Toxicity is an European Pharmacopoeia standard for assessment of biological products and the test material is administered to the mice. In this study, abnormal toxicity of IPM was evaluated in experimental animal model such as mice.

Materials and Methods: In this experimental study, infusible platelet membrane (IPM) was prepared from outdated platelet concentrates. Platelet concentrates were pooled, disrupted by freeze-thaw procedure, pasteurized for 20 hours to inactivate the possible viral or bacterial contaminants with a sodium caprylate stabilizer, formulated by sucrose and human serum albumin and finally lyophilized. We injected 0.5 ml of IPM (2 mg/kg) intravenously into each 5 health mice, weighing 17-22 grams.

Results: According to the EU Pharmacopeia, the test will be passed if none of animals die during 24 hours after injection. If more than one animal dies, the preparation fails the test. If one of the animals just dies, the test is repeated. In our experiment all five mice were alive.

Conclusion: In this research the results showed that IPM as a platelet substitute is free of abnormal toxicity and safe and it may be used in human clinical trial studies as a feasible approach to develop a platelet substitute in the future. However, further studies are required to confirm the different aspects of its safety as well.

Key words: Infusible Platelet Membrane, Platelet Substitute, Toxicity

 

Funding: This research was funded by IBTO-Research Center.

Conflict of interest: None declared.

Ethical approval: The Ethics Committee of Tehran. Azad University, approved the study

 

How to cite this article: Jafar-Gholizadeh S, Nasiri S, Mirabzadeh Ardakani E, Seyfkordi A. Evaluation of Toxicity Test on Infusible Platelet Membrane in Mice: A Short Report J RafsanjanUniv Med Sci 2015 13(11): 1091-6. [Farsi]

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Type of Study: Research | Subject: Hematology
Received: 2014/08/3 | Accepted: 2015/03/9 | Published: 2015/03/9

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