S. Jafar-Gholizadeh, S. Nasiri, E. Mirabzadeh Ardakani, A. Seyfkordi,
Volume 13, Issue 11 (3-2015)
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platelet membrane (IPM) from fresh or outdated human platelets correct the prolonged bleeding times in thrombocytopenic animals such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membrane (IPM) was prepared from outdated platelet concentrates.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]