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Decision Support Tools for Regenerative Medicine: Systematic Review.
Ching Lam1,2, Edward Meinert2,3, Abrar Alturkistani3
1Department of Engineering Science, Institute of Biomedical Engineering, University of Oxford, Oxford, United Kingdom.
Journal of Medical Internet Research
|December 21, 2018
Summary
Decisional tools are crucial for manufacturing and commercial decisions in regenerative medicine. However, current tools are limited, especially for autologous cell therapies, tissue engineering, and gene therapies, highlighting a need for development.
Area of Science:
- Regenerative Medicine
- Biotechnology
- Decision Science
Background:
- Decisional tools are vital for informed manufacturing and commercial decisions in the monoclonal antibody field.
- Regenerative medicine therapies offer significant clinical benefits to patients.
Purpose of the Study:
- To review available decisional tools for regenerative medicine.
- To identify issues and gaps in the application of these tools.
Main Methods:
- Systematic search of MEDLINE for decision support tools in tissue engineering, cell, and gene therapy.
- Inclusion of English-language studies describing decisional tools in regenerative medicine.
- Quantitative and qualitative data extraction and assessment.
Main Results:
- Nine articles were identified, focusing on cell therapy manufacturing and product development challenges.
- All identified tools specifically addressed cell therapies, with most focusing on allogeneic products.
- No decisional tools were found for tissue engineering or gene therapy products.
Conclusions:
- A limited number of decisional tools exist for regenerative medicine compared to established fields like monoclonal antibodies.
- Significant opportunities exist for developing decisional tools for autologous cell therapies, tissue engineering, and gene therapies.
- Comprehensive modeling of the entire process is recommended for future development.
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