|In order to turn islet transplantation into a widely acceptable cure for diabetes, an unlimited source of islets has to become available, and immunosuppressive strategies to prevent rejection need to be optimized.Research teams around the country and the world have launched projects designed to overcome the immune response, which is needed to prevent rejection of transplanted pig islets.
The goal is to have suitable donor pigs available at the same time immunosuppressive treatment is safe for human clinical trials. Spring Point Project builds and operates the biosecure facilities to raise high-health pigs for islet transplantation in humans.
We are a nonprofit organization that operates a barrier facility to raise designated pathogen-free (DPF) pigs for use in biomedical research, with the primary focus of supplying porcine cells/tissue for use in islet cell xenotransplantation to treat Type 1 diabetes.
DPF pigs are pigs free of many pathogens, including those that could potentially transmit disease from pig to human. To ensure animals are of DPF status, selected pigs are introduced into the barrier facility via caesarean section and then maintained as a closed herd. Subsequent generations, the source animals, are bred from the progenitor animals and are raised and housed in the barrier facility environment where the animals are not exposed to potential pathogens – air is filtered, water is disinfected, and feed is irradiated and certified free of any mammalian products.
A barrier facility is a facility designed to keep contaminants out (i.e., maintain pathogen-free status). Barrier facilities consist of several essential elements: stocking animals known to be free of pathogens, appropriate siting and design of internal environments, rigorous management of the physical plant, and regular monitoring of pathogen status.
Unlike conventional commercially produced pigs, Spring Point Project pigs are bred and raised in a biosecure barrier facility. Potentially pathogenic bacteria and viruses have been removed from the pig herd and the animals are housed in an environment that remains free of infectious agents. The animals are rigorously monitored and tested to ensure the DPF status of the animals is maintained. Animal housing is in full compliance with guidelines and regulations allowing for certifications from the U.S. Department of Agriculture (USDA) and the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). The facility and the source pigs are suitable for clinical applications as described in the organization’s Biologics Master File (BMF) submission to Food and Drug Administration (FDA).
Spring Point Project (SPP) is the only producer of FDA-‘approved’, clinically suitable porcine materials in the United States. (Note: The FDA doesn’t grant approval per se, but has stated that SPP has satisfactorily complied with FDA guidelines and addressed their concerns based on our BMF submission-hence the quotations.) As a result, SPP is ‘approved’ to supply organs and tissues from SPP pigs for xenotransplantation clinical trials.
Xenotransplantation is a procedure that involves the transplantation, implantation or infusion into a human recipient of live cells, tissues or organs from a nonhuman animal source. The development of xenotransplantation is, in part, driven by the fact that the demand for human organs for clinical transplantation far exceeds the supply.
Insulin-producing beta cells are part of clusters of cells in the pancreas called Islets of Langerhans that help regulate blood glucose levels. In Type 1 diabetics, the beta cells are destroyed by an autoimmune process and the patient must receive insulin injections to maintain proper glucose levels.
In Type 1 diabetics, the beta cells are destroyed and the patient must receive insulin injections to maintain proper glucose levels. If the defective beta cells can be replaced (i.e., transplantation of new cells from a donor), proper glucose levels can be restored, thereby eliminating the need to receive daily insulin injections and the complications that result from blood glucose level fluctuations.
The risk of transmitting disease to humans by transplanted pig organs, particularly islets, using designated pathogen-free pig donors actually might be less than the current risk associated with transplanting islets from deceased human donors. Like other species, pigs have so-called endogenous retroviruses, which by their very nature cannot be removed by conventional breeding. However, there is no unequivocal evidence that such viruses can infect recipients and cause disease upon transplantation.
The Spring Point Project facility design and the health status of animals have been documented in a submission to the U.S. Food and Drug Administration (FDA). Spring Point Project has received a favorable response from the FDA stating that the design of the facility is adequate to maintain a high health status. The facility’s Biologics Master File (BMF) has been accepted by the FDA and the facility has been deemed satisfactory to provide animals for use in clinical applications – the highest level of “approval” awarded by the FDA.
We’re identifying and working with researchers around the country and the world to use as much of the porcine material (the special organs, tissues, and cell lines from our pigs) as possible to further their research efforts. Much of the tissue is currently being used for diagnostic testing required to assure us and the FDA that the materials are suitable for clinical use.
The development process to begin clinical trials is a long one. Although SPP cannot say for certain when a cure will be reached, we feel the replacement path using porcine islet cells – the path we’re currently on – will lead to the quickest, most reliable diabetes cure. We will continue to provide updates on our progress via our website and e-newsletter.
SPP is squarely positioned in the middle of three of distinct paths to a cure:
Tolerance is a term used to describe what happens when we convince the immune system that the transplanted, in this case pig, tissue is not foreign but is part of the body. Tolerance strategies currently being pursued by Dr. Hering include negative vaccination, surface modification and genetic modification of pig islets. These strategies, if successful, promise to eliminate the need for any long term immunosuppression – many people’s definition of a cure.
Understanding what causes the autoimmune destruction of islet cells is an important part of this path. The difference in how pig islets are rejected compared with how human islets are rejected may lead to an answer – and SPP is prepared to supply the pigs necessary to this research.
Stem cell research is another major research direction for the regeneration pathway. Once the autoimmune destruction of islet cells is halted, stem cells could serve as the source for self-replacement of islets. While extremely promising, stem cell technology has technological hurdles that we believe will delay, not prevent, their use until much after replacement paths have proven successful.
Therefore, it’s likely pig islets will serve individuals in need now while stem cells will likely serve future needs.
Yes, SPP has plans in place for expansion of its current facility as well as long-term plans to expand into additional facilities when timing is right.
Being a nonprofit organization allows us to combine the support of our many philanthropic donors with the revenue from customers who purchase our porcine materials. As a result, we are able to minimize the cost of porcine materials to our researchers. This enables us to create the lowest-cost islet product possible and, therefore, more research money can be used for science instead of raw material supply (pig islet cells).
We will continue to grow in order to do whatever it takes to cure diabetes. We will not give up!
There are many ways you can contribute to the cure. Make a monetary donation or advocate SPP’s mission by sharing our story with friends, neighbors and coworkers. Help us get the word out that hope is on the way!