Efficacy and safety of recombinant human bone morphogenetic protein-2 biomaterials in promoting bone regeneration: A systematic review and meta-analysis
Yue Li1,2
, Jun Zhao1,2, Chunxia Chen1,2
1Department of Prosthodontics, Tianjin Stomatological Hospital, School of Medicine, Nankai University, Tianjin City, China
2Tianjin Key Laboratory of Oral and Maxillofacial Function Reconstruction, Tianjin City, China
Keywords: Bone regeneration; heterogeneity, machine learning, network meta-analysis, recombinant human bone morphogenetic protein-2, safety, systematic review.
Abstract
Objectives: This study aims to systematically evaluate the efficacy and safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) in promoting bone regeneration.
Materials and methods: A comprehensive search of PubMed, Embase, Web of Science, and Scopus was conducted from inception to May 2024. Fifteen randomized-controlled trials involving 2,137 cases were included. Traditional and network meta-analyses were performed, machine learning techniques were applied to explore heterogeneity, and subgroup analyses were carried out to assess efficacy across anatomical sites including alveolar sockets, palatal clefts, and spinal fusion.
Results: No significant difference was found in the overall bone healing rate between the rhBMP-2 and control groups (relative risk [RR]=1.02, 95% confidence interval [CI]: 0.87- 1.20). However, rhBMP-2 demonstrated a significant advantage in spinal fusion (RR = 1.09, 95% CI 1.01–1.17) and a positive, although not statistically significant, trend in small oral and jaw bone defects. The incidence of serious adverse events was comparable (RR = 0.97, 95% CI 0.66–1.42). Network meta-analysis indicated that the overall success rate of bone regeneration with rhBMP-2 (odds ratio [OR] = 1.53, 95% CI 0.54–4.33) and other bone substitutes (OR = 1.42, 95% CI 0.39–5.21) did not significantly exceed autograft treatment, although both showed a trend toward superiority. Direct pairwise comparison revealed that rhBMP-2 was significantly more effective than autograft (OR = 1.54, 95% CI 1.02–2.33, p < 0.05), with low heterogeneity (I2 = 0%).
Conclusion: While the overall healing rate was comparable to controls, rhBMP-2 showed significant efficacy in spinal fusion and a favorable safety profile. Its effectiveness was context-specific, influenced by anatomical site and patient factors. These findings support the selective use of rhBMP-2 in specific clinical contexts such as spinal surgery, while further research is needed to optimize its application in other indications.
Citation: Li Y, Zhao J, Chen C. Efficacy and safety of recombinant human bone morphogenetic protein-2 biomaterials in promoting bone regeneration: A systematic review and meta-analysis. Jt Dis Relat Surg 2026;37(x):i-xix. doi: 10.52312/jdrs.2026.2523.