At the 14th World Congress of International Pancreas transplantation and Islet Transplantation Association (IPITA) meeting at Monterey, CA (24-27 September 2013) 441 scientists from 34 different countries attended the meeting to discuss the new discoveries in islet and pancreas transplantation. Among significant reports of advance in transplantation techniques and outcomes surprisingly a decrease in US transplant activity was identified due to economic constrains ¹ , ².
At a time where therapies such as islet transplantation is reaching the better outcomes reported so far, the US number of transplants is affected due to the diminishing grant opportunities, an intense and long regulatory process and lack of insurance coverage. Canada, United Kingdom, Switzerland, Belgium, Nordic Countries (Denmark, Norway, Sweden) and Australia are some of the countries that have recognized the full potential and benefits of islet transplantation and approved full national or regional health coverage for this medical treatment ³. Such coverage allowed not only for the increase in transplant activity but also it is a huge incentive for development of new science in this field. For the first time in history other countries are outperforming the US in islet transplant activity.
Several islet transplant centers from US, Canada and Europe reported long term insulin independence after islet transplantation as well as resolution of severe hypoglycemia. Dr. Camillo Ricordi, MD, University of Miami, and chair of the NIH Clinical Islet Transplantation Consortium, which is conducting FDA Phase II and III trials of islet transplantation alone and islet after kidney transplantation reported an update on CIT trials and future perspectives. Dr. Ricordi announced: “the first phase III multicenter trial completed enrollment, a paper on the primary endpoints is in preparation and a series of manufacturing and clinical reports will be submitted to FDA in 2014. The NIH CIT Consortium required a multidisciplinary and highly collaborative effort with cross-training, standardization and resolution of several cell product manufacturing challenges. It took years to standardize cell product manufacturing at the selected processing sites. Now that we have made significant progress, we are concerned about the future of islet transplantation in the US, as we will have to wait 2-3 years for a biological license application to be considered and hopefully approved by FDA. In addition, FDA approval will not mean automatic insurance reimbursement in the United States. In this context, islet transplant activities in the US will be limited by funding restrictions while the new leading centers in the field will continue to develop novel and improved strategies outside of the United States, where islet transplantation is already an approved and a reimbursable procedure. In fact, Edmonton (Canada) and Geneve (Switzerland), already did more transplants in one year compared to the entire NIH CIT consortium in the 7 years of its existence. These are elements that should make us reflect on how the complexity of the regulatory system and the time/cost to bring cellular therapies through a phase III trial may affect the ability of islet transplantation to move towards the next quantum leap in some countries, while islet transplantation is already approved and can move ahead much faster and more efficiently in others.”
The Islet Transplantation Association (IPITA) celebrated its 25th anniversary and an honor ceremony was held for the IPITA first council members and founding members: Rodolfo Alejandro (Member of first Council); Jean Jacques Altman; Camillo Ricordi; Yohichi Yasunami; Daniel Pipeleers; Reinhard G. Bretzel (Founding Members); Jean-Michel (Max) Dubernard; Raymond V. Rajotte; David W. Scharp; Reinout van Schilfgaarde; Guido Pozza; Derek Gray; Carl G. Groth; Tom Mandel (In Memorian) (Founding Members and Members of the First Council). The new elected president of IPITA, Bernhard Hering, MD, University of Minnesota, importantly noted that “Pancreas and islet transplantation are the only therapies for type 1 diabetes that reliably protect against hypoglycemia and that have the potential to reverse microvascular damage caused by hyperglycemia. We must continue this important work” ⁴.
Several new reports in insulin producing cells, stem cell therapy, anti-inflammatory and immunosuppressant transplant therapies, prevention of the recurrence of autoimmunity, new islet transplant sites and devices for transplantation were reported at IPITA ⁵. The field continues its scientific progress, however many answers are still needed for achievement the ultimate cure for diabetes. Peter Stock, MD, PhD, UCSF surgeon, chair of the IPITA World Congress, stated, “If we stop funding islet work, we will lose the infrastructure for curing diabetes through beta cell replacement at a point where we have encouraging treatments. New advances promise to make these therapies even more successful and more widely applicable” ⁶.
Hopefully, in the near future, some of the advances discussed at IPITA will receive suitable funding and the impact of diabetes might be ameliorated by new promising cell therapies.

References

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