Spinal cord injury (SCI) is a neurological disorder that causes permanent paraplegia or tetraplegia and currently, there is no effective therapy for it. Different biomaterials have been tested for the treatment of SCI, one of the most promising is plasma-synthesized polypyrrole (PPy) doped with iodine (PPy/I), which has demonstrated that protects nervous tissue from damage after a SCI, decreases lipid peroxidation and hydroxyl radical levels, inhibits pro-apoptotic molecules, favors nerve regeneration and allows the recovery of lost functions. Therefore, in order to propose the safe use of PPy/I for the treatment of SCI in humans, and according to ISO 10993-5:2009, cytotoxicity was evaluated in vitro by means of a viable count exclusion assay in the Escherichia Coli strain AB1157 and by the mitotic index in human lymphocytes cultures; mutagenicity by the Ames test in Salmonella Typhimurium; and genotoxicity by SOS chromotest in Escherichia coli strain PQ37 and by numerical and structural chromosomal aberrations in human lymphocytes cultures. The results indicated that in the concentration range tested plasma-synthesized PPy/I showed no cytotoxic effect, nor alterations in the mitotic index of lymphocytes, nor mutagenic activity against Salmonella typhimurium, and it also showed no alterations in the diploid number of chromosomes of lymphocytes, nor in the frequency of chromosomal aberrations, and the level of genotoxicity was classified as non-genotoxic (induction factor (IF) < 1.5). This means that plasma-synthesized PPy/I can be considered a safe therapeutic alternative for SCI.
The work was supported by the Mexican Institute of Social Security (IMSS), financing number FIS/IMSS/PROT/IT19/1882 and 2022 Project for Reactivation of Protocols. Stephanie Sánchez-Torres receives a scholarship from CONAHCyT to carry out her postdoctoral studies (CVU 422267).
We appreciate the technical support provided by Vadim Perez Koldenkova from the National Laboratory of Advanced Microscopy-IMSS, National Medical Center Siglo XXI, CDMX, Mexico.