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For medical devices it might be mechanical engineering, clinical trials, regulatory approval, freedom to operate (intellectual property) and figuring out a reimbursement strategy.
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Few studies have demonstrated the possible use of workflow modeling and analysis towards re-engineering clinical trials [5], [9], [10], and research in this area continues to suffer from the lack of standard representation model.
Among many challenges in tissue engineering prior to its clinical trials is the assessment of mechanical properties of engineered tissues.
Despite the many successful animal studies, few tissue-engineering approaches have progressed to clinical trials.
Cardiac cell therapy and tissue engineering have attracted considerable attention and clinical trials are ongoing to assess clinical efficacy and accommodate translation to the clinic.
More than 230 clinical trials of genetic engineering techniques are now in progress, but most are at a preliminary stage and none has yet led to an approved therapy.
These results indicate that BMCs seeded onto a biodegradable scaffold to establish tissue-engineered vascular autografts (TEVAs) is an ideal strategy, and present strong evidence for the justification and validity of our protocol in clinical trials of tissue engineering.
Ex vivo gene therapy based on CD34+ hematopoietic stem cells (HSCs) has shown promising results in clinical trials, but genetic engineering to high levels and in large scale remains challenging.
Under his direction, the Tiantan vaccinia virus strain was used for the genetic engineering of antigen expression, resulting in clinical trials of several recombinant vaccine candidates.
Tissue engineering has given several successes in primary clinical trials of regenerative medicine using biodegradable scaffolds.
Progress in genetic engineering and cloning may soon lead to clinical trials in xenotransplantation.
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CEO of Professional Science Editing for Scientists @ prosciediting.com