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Published on: May 25, 2017
Challenges in the Development of Biological Approaches for the Treatment of Degenerative Disc Disease
Jacob L Goldberg1, Andrew Garton1, Sunidhi Singh1
1Department of Neurological Surgery, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, USA.
Abstract:
There are numerous innovative and promising approaches aimed at slowing, reversing, or healing degenerative disc disease. However, multiple treatment-specific impediments slow progress toward realizing the benefits of these therapies. First, the exact pathophysiology underlying degenerative disc disease remains complicated and challenging to study. In addition, the study of the spine and intervertebral disc in animal models is difficult to translate to humans, hindering the utility of preclinical research. Biological treatments are subject to the complex biomechanical environment in which native discs degenerate. The regulatory approval environment for these therapeutics will likely involve a high degree of scrutiny. Finally, patient selection and assessment of outcomes are a particular challenge in this clinical setting.
Insights
Innovative treatments for degenerative disc disease face challenges. Overcoming complex pathophysiology, preclinical translation issues, biomechanical factors, regulatory hurdles, and patient assessment difficulties is crucial for therapeutic progress.
Area of Science:
- Biomedical Engineering
- Regenerative Medicine
- Orthopedics
Background:
- Degenerative disc disease (DDD) presents significant challenges to developing effective treatments.
- Numerous promising therapies aim to slow, reverse, or heal DDD, but face substantial impediments.
- Understanding the complex pathophysiology and biomechanical environment of the intervertebral disc is critical.
Purpose of the Study:
- To identify and discuss the key challenges hindering the clinical translation of innovative degenerative disc disease therapies.
- To provide insights into the multifaceted obstacles faced by researchers and clinicians in the field of DDD treatment.
Main Methods:
- Literature review and synthesis of current research on DDD pathophysiology and treatment modalities.
- Analysis of preclinical research limitations, including animal model translation issues.
- Examination of biological treatment constraints within the native disc biomechanical environment.
- Discussion of regulatory pathways and clinical trial design challenges, including patient selection and outcome assessment.
Main Results:
- The pathophysiology of DDD is complex and difficult to study comprehensively.
- Preclinical research in animal models shows limited translatability to human DDD.
- The biomechanical environment of the spine poses challenges for biological therapies.
- Regulatory approval processes and clinical assessment of patient outcomes present significant hurdles.
Conclusions:
- Significant impediments related to pathophysiology, preclinical models, biomechanics, regulation, and clinical assessment must be addressed.
- Overcoming these multifaceted challenges is essential for advancing the development and implementation of effective DDD treatments.
- Further research and strategic planning are required to navigate these obstacles and realize the potential of innovative DDD therapies.
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