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  4. Safety study: is there a pathologic IGF-1, PDGF and TGF-β cytokine expression caused by adjunct BMP-7 in tibial and femoral non-union therapy?

Safety study: is there a pathologic IGF-1, PDGF and TGF-β cytokine expression caused by adjunct BMP-7 in tibial and femoral non-union therapy?

Therapeutics and Clinical Risk Management, 2018 · DOI: http://dx.doi.org/10.2147/TCRM.S160064 · Published: January 1, 2018

GeneticsSurgeryOrthopedics

Simple Explanation

This study investigates if adding BMP-7 to standard non-union surgery affects cytokine expression during bone regeneration. The levels of IGF-1, PDGF-AB, and TGF-β were compared in patients receiving autologous bone graft (ABG) alone versus those receiving ABG with BMP-7. The study found similar cytokine expressions in both groups, suggesting BMP-7 is safe and doesn't cause abnormal systemic cytokine expression.

Study Duration
2009-2014
Participants
20 patients (10 in G1 treated with ABG and BMP-7, 10 in G2 treated with ABG only)
Evidence Level
Prospective, controlled study

Key Findings

  • 1
    IGF-1 levels were generally higher in the ABG-only group (G2) compared to the BMP-7 group (G1), but the overall course of expression was similar.
  • 2
    PDGF-AB expressions were almost equivalent in both groups throughout the study period, with peaks at 2 weeks post-surgery.
  • 3
    TGF-β expressions were also similar in both groups, with slightly higher levels in the BMP-7 group (G1) and a peak at 2 weeks post-surgery.

Research Summary

This prospective safety study evaluated the impact of BMP-7 on cytokine expression in non-union therapy by comparing IGF-1, PDGF-AB, and TGF-β levels in patients treated with ABG alone versus ABG with BMP-7. The study found uniform courses of serum cytokines in both groups, indicating that BMP-7 does not cause any pathologic reaction. The study concludes that BMP-7 administration in non-union treatment is molecularly safe and comparable to ABG therapy without causing abnormal systemic cytokine expression.

Practical Implications

Safety of BMP-7

The study supports the safety of using BMP-7 as an adjunct therapy in non-union treatment without causing abnormal cytokine expression.

Clinical Utility of Cytokine Analysis

Serum cytokine expression analysis can be a helpful method for evaluating the safety of growth factor-based non-union treatments.

Further Validation Needed

The findings need to be validated in studies with larger patient numbers to confirm the safety and efficacy of BMP-7 in non-union therapy.

Study Limitations

  • 1
    Low number of included patients
  • 2
    Perfect matching regarding patients’ age was not possible
  • 3
    Differences in the age of samples could influence the cytokine concentrations

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