Tissue Engineering and Regenerative Medicine

The research field of tissue engineering and regenerative medicine has experienced a tremendous growth in the last decade with several technologies showing promising results in pre-clinical studies and ready to be translated from the bench top to the bedside.

Although some clinical trials have already started, this aspect is still in its infancy and there is a big gap of knowledge both from the scientific and from the regulatory side. As most of the technologies involve a combination of scaffolds, cellular components and growth factors, the regulatory entities are still debating whether the existing committees should incorporate the regenerative medicine field as part of their tasks or if new committees should be created to attend these specific matters.

On the other hand, the complexity involved in many of the technologies, particularly those involving cell cultures, creates the necessity of additional steps in the design of a clinical trial compared to pharmacological or medical devices areas. In the cases that involve the use of autologous cells, a former biopsy is usually needed from the patient and a time-consuming fabrication process is often required until the final product can be implanted in the patient. That fabrication process has to be done under GLP conditions and needs to be considered as part of the trial. All the aspects mentioned above, make the clinical translation of tissue engineering technologies a complex and delicate issue that most of the CROs worldwide are not familiar with.

Research & Development RA SA approach to meet the requirements and necessary training to meet the needs of our clients involves the participation of established scientists in the tissue engineering and regenerative medicine field for designing, coordinating and executing the clinical trials for these new technologies. Dr. Alejandro Nieponice, our chief scientific advisor specially recruited for this purpose is a pioneer in the clinical translation of regenerative medicine technologies.

Under his supervision we are able to provide to Tissue Engineering companies with all the particular details required for the clinical translation of these innovative technologies including the contact with a GLP facility to fabricate the constructs in the country, the supervision of the manufacturing process, the particular biologically safe transportation conditions, and the implementation of the appropriate surgical techniques with the most adequate surgical team.

We are also in close contact with the regulatory entities to provide feedback on a frequent basis to facilitate the creation of new norms and regulations to help improve the safety and seriousness of translational research. If you are trying to translate a new technology within the area of regenerative medicine, either coming form the industry or the academia, do not hesitate to contact us and we will make sure to find a solution for your needs.


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