Entries Tagged 'xenotransplantation' ↓

IXA Statement on Xenotransplants for Type 1 Diabetes

For those of you following developments in the field of xenotransplantation, the International Xenotransplantation Association (IXA) has recently developed a proposed Consensus Statement on Conditions for Undertaking Clinical Trials of Porcine Islet Products in Type 1 Diabetes.

In my quick read of the statement it appears to be a comprehensive, well thought out document that encompasses ethical and public health considerations as well manufacturing, preclinical and clinical considerations.    The statement was drafted by an number of thought leaders in the field, such as Bernhard Hering, Greg Korbutt, Clive Patience, Harold Vanderpool and Henk-Jan Schuurman.  It also appears that the FDA provided some informal feedback on the statement, since Keith Wonnacott from FDA is mentioned in the acknowledgments.

I get the general impression that many assume the field of xenotransplantation is “dead,” because of  the challenges the field has faced due to public health concerns such as porcine endogenous retrovirus (PERV).  However, it appears the field has now been able to largely address those concerns.

Since it is clear that there continues to be  large unmet medical needs that are not yet met by any existing medical products, there has been a small but dedicated group of individuals who are attempting to determine if animal-derived cells and tissues can help.  In my view, xenotransplantation, as a cell replacement therapy,  fits within the scope of regenerative medicine.

I think this consensus statement from IXA represents one example of how complex areas of medical research, which raise an number of important issues in the minds of the public, can progress in a responsible manner.  Let me know your thoughts in the comments.

–Darin

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