Entries Tagged '4Rs' ↓

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.


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My 2008 Presentations & Articles Relevant to Regenerative Medicine

2008 was an extremely busy year for me, as I am sure it was for you as well. The net result is that I have been slow to post updates and thoughts regarding translation of regenerative medicine products to the clinic. In the ‘better late than never” category, I thought I would share some of the presentations and relevant articles I have written over the past year.

Links are provided for most of the presentations and articles I have generated over the past year.

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What the Heck is a Regenerative Medicine Therapy?

My favorite working definition for regenerative medicine is any medical intervention that is intended to repair, replace, restore or regenerate (the 4 R’s) the cellular, tissue or organ systems in the human4Rs.jpg body. As described by one of my former FDA colleagues, Dr. Steven Bauer, cellular therapies represent one branch of regenerative medicine that on their own can fulfill the 4 R’s. However, it is clear that many other medical technologies will contribute to the field of regenerative medicine. See my post on how the FDA views the world of regenerative medicine.

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