Frequently Asked Questions

Q. What does this latest research in the treatment of diabetes mean for diabetics?
A. Researchers at the University of Minnesota have achieved prolonged reversal of diabetes via transplantation of pig islets in monkeys, one step away from humans.

Pig islet graft survival was made possible with a novel immunosuppressive protocol. Survival required neither genetic modification of donor pigs nor coating or encapsulation of donor islets.

These results mark a turning point in developing islet replacement therapies into a viable and widely available solution for type 1 and potentially type 2 diabetes.

The research team also identified critical pathways involved in immune recognition and rejection of pig islet transplants.

Targeting these pathways with more selective and safer immunosuppressive therapies is the focus of current research. Successful completion of these studies may make initiation of clinical trials in humans possible in the next years.

Q. What is Spring Point Project?
A. Spring Point Project was created as a nonprofit, grassroots effort to produce an abundant supply of safe pigs for the clinical trial phase, and ultimately to contribute to a cure for diabetes.
A. Researchers have already had success reversing type 1 diabetes in humans through transplantation of islets from human donors; however, the demand for islet cells grossly outweighs the supply. In order to make islet transplantation a viable solution for the thousands of people with difficult to manage diabetes, a safe and reliable source of islet cells must be found.

To that end, Spring Point Project has built and operates a biosecure barrier facility to raise high-health "medical-grade" pigs as suitable donor animals in compliance with federal regulations for planned pig islet transplant trials in humans.

Completion of the stringent tasks required for FDA approval to use pig islets in clinical trials can be accomplished within the next years.

Q. If you are nearing clinical trials with humans, why did you need to build the Spring Point facilities?
A. As the Nature Medicine article documents, pig islets are a viable alternative to human donors. We needed to solve the supply side of this equation in order to quickly translate the University of Minnesota research into an available diabetes therapy.

The FDA has strict guidelines to assure the safety of pig islets for transplantation into humans. As a result, it takes several years to breed the special pigs we will need for transplantation. So we needed to build the facilities in order to keep up with the pace of science. Both the science and the pig supply needed to be on parallel tracks.

Q. Is Spring Point Project for-profit or nonprofit?
A. Spring Point Project was created as a nonprofit organization. This means that university researchers collaborating with Spring Point will not have an equity share. As a result, they will be able to continue their research program without conflict of interest.

Q. Can disease be transmitted from pigs to humans through islet transplantation?
A. There is no real-world evidence that pathogens, such as retroviruses, can be transmitted to humans through pig islet transplantation. In fact, evidence indicates that the risk of transmitting disease to humans by transplanted pig organs, particularly islets, should actually be less than the current risk associated with transplanting islets from deceased human donors.

Humans have had extensive exposure to pig tissue without disease. Some examples of this include: pigs as a meat source, pig heart values, pig insulin, pig brain cell transplants for treatment of Parkinson's disease, and pig skin transplants, to name a few.

Q. When were the buildings be completed? What is yet to be completed and when is it scheduled to happen?
A. The facility in eastern South Dakota was completed and populated with animals beginning in 2005. The highly biosecure Source Animal Facility, the Diabetes Research and Wellness Islet Resource Facility, capable of producing animals whose islets are suitable for human transplantation was completed in February 2007. The facility was populated in 2007 and the internal breeding program commenced in 2008. Source Animals resulting from this breeding program will support preclinical work in 2008-2010 and, following regulatory approval subsequent clinical trials are slated to begin.

Q. When can we pass the information along to others?
A. Now! Excitement about the project is building. Our website is live, we're generating press coverage, and we want to spread the word!

Q: Why is SPP using a nonprofit model instead of for profit?
A: 1. Stability and control. The nonprofit model provides a platform for commitment to xenotransplantation that is insulated from the market and decisions made by Pharmaceutical companies, who have in the past made fleeting (although significant) investments into the approach.
2. Integrity. Given that the business is nonprofit, University researchers collaborating with the nonprofit will not have an equity share. Therefore, they will be able to continue their research program without conflict of interest and will continue to have access to public research funding mechanisms.
3. Charitable Contributions. The nonprofit model provides a mechanism for tax deductible investment from philanthropists intent on finding a cure for diabetes.
4. Small business grants. The nonprofit will have access to local, state, and federal funds supporting the development of small businesses.
5. Cost containment. The inclusion of businessmen on the board of directors will provide expertise and oversight to keep costs low. In addition board members will volunteer their time.
6. Licensing. A nonprofit provides a mechanism for moving University of Minnesota technologies into the clinic. Although the nonprofit will not show returns from licensing agreements, they will transfer technologies (via sub-licensing) into the private health care sector where such returns can be realized. This provides resources for continued investment into the nonprofit, as well as returns to the University of Minnesota in the form of royalties.