This week the journal Tissue Engineering published a Special Issue dedicated to papers presented at a workshop titled ‘Translational Models for Musculoskeletal Tissue Engineering and Regenerative Medicine’, held in December 2008, preceding the TERMIS-NA meeting in San Diego. Dr Sah (UCSD), Dr Wang (NIH) and I were the co-organizers of the workshop and guest editors of the publication. The objective of the Workshop was to have an open and detailed discussion of the animal models used in this field, their advantages and disadvantages, and highlight particular gaps and needs. The models are a necessary if undesirable component of medical research and product development, and we all wish to ensure the most effective use of these studies. The workshop was a success (attendance was 2.5 times the initial expected attendance), but its lasting impact is the publication of these manuscripts, describing the pros and cons of the field today, and highlighting needs for improvement. An excellent example is the paper presented on models for studying rotator cuff repair, including the model used in the assessment of X-Repair where effectiveness in a challenging and relevant pre-clinical model was a key observation for us to move forward into clinical use of the product.

An important component of the workshop was the presentation by the FDA, now solidified as a manuscript in the Special Issue. Of course the FDA is a critical component of any development pathway for medical products, and more and more they show evidence of reaching out to those involved in research and product development to help ensure that the needs of the agency are met, trying to maximize efficiency of medical product development while ensuring safety of the American pubic. Their continued participation is welcomed!

It is intended that the workshop and subsequent publication serves as a springboard to enhancing the models available, and perhaps move some of these models into more formal standards as developed and published by ASTM. Already there are signs of this occurring with increased activity at ASTM suggesting the efforts made in getting to this stage have been worthwhile. It remains to be seen if these early signs of success are converted to reality, but he indications are positive. The field needs these translational models to effectively assess effectiveness/efficacy and safety of new potential medical products, many addressing unmet clinical needs. It is now in the hands of the researchers to put in place validated models meeting specific clinical problems that can be addressed by tissue engineering and regenerative medicine.

An important feature of bringing new technologies to clinical use is the exchange of information by clinicians, achieved by presentations at meetings as well as by publications of articles in clinical journals. The first clinical presentation involving X-Repair was given at the San Diego Chapter meeting of the Western Orthopaedic Association meeting, held on 1/29/2010. The meeting had an interesting format with each presenter given a topic and asked to discuss ‘what’s hot and what’s not’; a great way for everyone to get an update on current issues in orthopaedics. Dr Lane presented on Shoulder, and included a discussion and showed a video of his early use of X-Repair in arthroscopic repair of major rotator cuff tears.

These are early days in the introduction of X-Repair, but the presentation of some clinical experience is a very positive advance for the product. We are looking forward to Dr Lane continuing to gain experience with the product, and eventually converting these observations to a published manuscript.

An important X-Repair milestone was achieved recently when the tenth rotator cuff repair using X-Repair was performed. This has been using multiple surgeons and both arthroscopic and open procedures. So far the results have been excellent as assessed by clinical exam and imaging (ultrasound). The first surgery using X-Repair was done 20 weeks ago. A great beginning to gaining clinical experience!