Who We Are New Lifeabetes Supports and is the bridge to diabetics interested in the Hopeful soon to be Cure For Diabetes believing and working side by side with Spring Point Project and its supporters. New Lifeabetes Goal is to provide quality credible information and support to diabetics worldwide for the best possible quality of life and to prepare diabetics mental and physical health to cross over to a New Lifeabetes and prepare diabetics for the CURE! We passionately Believe Spring Point Project is the soon to be Diabetes CURE and invite you to read the information below please contact us with any questions you may have direct at newlifeabetes@yahoo.com We are working on our website and will hopefully have it up in a few months. We respectfully ask you not to contact Spring Point Project direct their mission is to stay focused on their research and their time needs to be concentrated on just that.

Spring Point Project is a non-profit corporation formed September 23, 2004 in Minnesota, with the mission: To expedite the widespread availability of islet tissue for diabetes care by developing premier source pigs for islet xenotransplantation.

Spring Point Project has obtained 501(c)(3) tax exempt status from the IRS. It is presided over by a Board of Directors who have ownership of the corporation. The company works in partnership with the Diabetes Institute for Immunology and Transplantation at the Department of Surgery of the University of Minnesota, where the pre-clinical work in models of transplantation is performed and where clinical studies are foreseen. The company collaborates with other scientists within and outside the University as well. The budgetary implications for collaborating institutions are attached

The objectives of Spring Point Project to achieve its mission:

Establish facilities to raise designated pathogen-free (DPF) pigs with genetics for high islet cell yield to be used for clinical islet xenotransplantation trials. Provide resources to perfect an immunosuppression regimen tailored to preventing rejection of transplanted porcine islet cells, and for the genetic improvement of pigs to minimize recipient immunosuppression and prevent the transmission of viruses. Develop DPF animals for and participate in clinical trials.

The most relevant milestone in realization of the mission is the start of first clinical trials foreseen in 2009. The work foreseen to reach this milestone in partnership with the Diabetes Institute includes:

Fundraising: the goal is to raise $20 Million by the end of 2008. Efficacy in pre-clinical studies conducted at the Diabetes Institute. Availability of DPF premier source animals to serve as donor for xenotransplantation Safety monitoring, including the potential of cross-species disease transmission. The Diabetes Research and Wellness Foundation (http://www.diabeteswellness.net/) is a major foundation supporting the work of Spring Point Project, which is gratefully acknowledged

To fulfill its mission, Spring Point Project has reached the following milestones (status December 2006), leading to the conclusion that our work is solidly on target to reach the objectives of initiating clinical trials in 2009:

Recruited Henk-Jan Schuurman, PhD, an extremely experienced researcher and executive in the field of xenotransplantation, to head Spring Point Project as its CEO (April). Completed the design of the Source Animal Facility (SAF), suitable for the production of animals meeting all regulatory requirements to yield islet tissue suitable for transplantation into humans (April). Purchased a suitable property in western Wisconsin on which to build the SAF, and initiated the construction of the 21,000 square foot, 6.2 million dollar facility (April/May). Celebrated a Groundbreaking Ceremony for this SAF (June). At the end of 2006, construction is on track for operations to begin in February 2007. Received favorable response from the FDA ..ted documentation regarding the design and flow processes through the SAF, and the DPF status proposed for animals generated in the facility (June). Sponsored research at the UMN to screen for and generate animals incapable of transmitting PERVs to humans (May). Introduced cesarean derived SPF piglets into Spring Point Project’s Multiplier Facility in eastern South Dakota to build the genetic diversity of the progenitor animals for Spring Point Project’s future programs (April/May). Convened the inaugural meeting of Spring Point Project’s Safety Advisory Board, a group of world renowned scientists in health management and infectious disease aspects of swine, in particular when kept in bio secure facilities like SPP’s Source Animal Facility. The Board assessed Spring Point’s facility design and the specifications of animals generated. The results of the assessments were incorporated into a regulatory submission to the FDA (April). Celebrated a Gala event announcing the public phase of the campaign to raise $20 Million (June). Passed $15 Million mark in funds raised at or above 75% of goal 2006-2008 (December). Initiated the hiring of staff for the Source Animal Facility: attracted Dr. Michael J. Martin, a well recognized expert in advanced swine reproduction technologies as Director of Animal Facilities, and Dr. Adrienne Schucker, a veterinarian with broad experience in regulatory affairs of swine husbandry (September).

MEET THE DOC

Bernhard J. Hering, M.D. Dr. Hering is Professor of Surgery, the Eunice L. Dwan Diabetes Research Chair, and Director of Islet Transplantation and Scientific Director of the Diabetes Institute for Immunology and Transplantation at the University of Minnesota. He is a member of the Steering Committees of several NIH-sponsored research consortia, including the Clinical Islet Transplant Consortium, the Immune Tolerance Network, the Human Islet Cell Resource Program, the Nonhuman Primate Transplantation Tolerance Collaborative Study Group, and the Immunobiology of Xenotransplantation Cooperative Research Program. He is co-director of the Juvenile Diabetes Research Foundation (JDRF) Islet Transplant Center at the University of Minnesota/University of California San Francisco. Dr. Hering co-founded the International Islet Transplant Registry and is Medical Director of the NIH-sponsored Collaborative Islet Transplant Registry (CITR). He has served as President of the Cell Transplant Society and as Councilor of the International Pancreas and Islet Transplant Association, and is a member of the Council of the International Xenotransplant Association. He sits on the editorial boards of several professional journals and has authored over 200 articles and 25 book chapters on islet transplantation. http://www.kare11.com/includes/buildasx.aspxfn=mms://wm.kare.gannett.edgestreams.net/news/news/090607_262894_cartier_kare.wmv213436524624&sp=http://wm.kare.gannett.edgestreams.net/news/sales/collsave.wmv

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 three 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 pig islets for the clinical trial phase, and ultimately to contribute to a cure for diabetes. Philanthropic gifts will be the sole source of capital for the Spring Point Project.

Q. Why is Spring Point Project important for this research and the treatment of diabetes?

A. Researchers have already had success reversing type 1 diabetes in humans through islet transplantation; however, the demand for islet cells grossly outweighs the supply. In order to make islet transplantation a viable solution for the tens of 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 will build and operate biosecure barrier facilities to raise high-health 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 three years. Estimates are that about $20 million will be needed to establish and operate Spring Point’s biosecure facilities where high-health pigs will be raised.

Q. If you are a few years away from clinical trials with humans, why do you need to build the Spring Point facilities now?

A. As the Nature Medicine article documents, pig islets are a viable alternative to human donors. We must now 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 will take several years to breed the special pigs we will need for transplantation. So we need to build the facilities now in order to keep up with the pace of science. Both the science and the pig supply need 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 diseases, called 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 will the buildings be completed? What is yet to be completed and when is it scheduled to happen?

A. The facility in eastern South Dakota is complete and being populated with animals at this time. This highly biosecure Source Animal Facility, capable of producing animals whose islets are suitable for human transplantation is scheduled to be completed in February 2007.

Q. When will human trials begin?

A. We anticipate that Phase 1 clinical trials will begin in 2008.

Q. When can we pass the information along to others?

A. Now! Excitement about the project is already building. Our Web site 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 Non Profit 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 non profit, University researchers collaborating with the non profit 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 non profit 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 non profit provides a mechanism for moving U of MN technologies into the clinic. Although the Non profit 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 non profit, as well as returns to the U of M in the form of royalties.