Evaluation of the potential immunogenicity of recombinant human bone morphogenetic proteins

Abstract

Introduction. Bone morphogenetic proteins (BMPs) are a subgroup of the transforming growth factor-β (TGF-β) superfamily where they play an important role in bone formation and repair. Recombinant human bone morphogenetic proteins (rhBMPs) are currently being clinically evaluated for their effectiveness in enhancing bone tissue regeneration processes after injuries and diseases of the musculoskeletal system. Clinical trials were accompanied by detailed safety assessments using both in vitro and in vivo assays. Concerns were initially raised about the immunogenicity of some therapeutic proteins due to their non-human origin. However, proteins derived from human serum or tissues and products derived from recombinant DNA, such as rhBMPs, identical or nearly identical to native human proteins, have also been shown to be immunogenic. The purpose. of this study is to review the potential immunogenicity of rhBMPs and compare the results of preclinical and clinical studies available to date between rhBMP-2 and rhBMP-7. Materials and methods. Using PubMed, Embase, the Cochrane Database, and Google Scholar, we conducted a comprehensive search for original papers, literature reviews, case reports, and meta-analyses demonstrating possible immune responses to rhBMPs. Results. This study analyzes possible reactions from the immune system when using rhBMPs in both clinical and preclinical studies. Antibody production has been found to be one of the side effects of rhBMPs. However, reported cases of immunogenicity of rhBMPs vary greatly due to the lack of standardization of methods. Conclusion. No immunologically related adverse events were observed in various clinical trials, and antibody formation never adversely affected new bone formation and clinical outcomes.