The Veterans National Recovery Center is a 501 (c)(3) charitable corporation first established in 2010 to bring awareness to the massive influx of Post-Traumatic Stress Disorder (PTSD) veterans back into America from the 911 Wars. Those veterans had needs that were not being met, and VNRC has worked that issue, as well as others such as Traumatic Brain Injury, Military Sexual Trauma (MST) and jobs. VNRC began to work in the field of skin regeneration in 2012. The group became aware of the many injuries caused by Improvised Explosive Devices (IED’s) during the war. A significant number of these were burn injuries, and it seemed to be a niche where little innovative was being done. In this process, VNRC worked jointly with the Swiss Consortium Partnership (SCP) discussed elsewhere, to develop a grant proposal.
The grant was tied to Hot Springs, South Dakota. The skin regeneration technology has a requirement for extensive hydrotherapy post-surgery in order to enhance healing and regeneration. In that grant application, a remodeled Castle Manor Nursing Home was to become a skin regeneration clinic and research facility. Although the grant application failed, VNRC developed knowledge from the exercise and continued to pursue the dream. The long history of review and consultation, allowed the VNRC to create a comprehensive proposal, working with elements within the Hot Springs community, as well as with medical technologists, economic development professionals, veterans and others .
Where is the Southwest South Dakota Medical Miracle Proposal?
The US Department of Veterans Affairs announced the creation of an Environmental Impact Statement (EIS) process in June 2014 with a comment deadline of August 16. The purpose of the process is to review the options available to the VA concerning the future of Battle Mountain VA Hospital in Hot Springs. By law, comments and proposals submitted through this process are required to have a formal review.
The VNRC has submitted its 112 page proposal as Alternative F under the EIS process as documented in this entry in The Federal Register.
Alternative F is identified as an “as yet unidentified alternative use that might be proposed during the EIS process.”
The EIS process is expected to be concluded before the end of 2014, and the decisions made in it will be presented to the VA for possible implementation.
What central technology concept undergirds this proposal?
Regenerative medicine technologies and follow-on convalescent technologies underpin much of this proposal. The term “regenerative medicine” as discussed here deals primarily with progenitor cells and their scientific application to renew the patient’s own body cells by stimulating stem cells in the patient’s own body to act in a favorable way. A progenitor cell grown in a lab can command that new skin can be grown where there is none because of a burn. A progenitor cell can likewise regenerate other parts of the body to create a nearly complete restoration, provided that the proper progenitor cell is identified and applied.
Regenerative medicine has passed its infancy, and is being used in different, narrower applications here in South Dakota even today.
The regenerative medicine technologies discussed here are from Switzerland. A group of Swiss academic researchers formed the Swiss Consortium Partnership (SCP) a number of years ago in response to the needs of the Swiss Army. The Swiss had decided near the end of the Cold War that mass burn casualties would be the most significant threat in the event of war, and funded a project to investigate possible solutions and technologies to deal with the war-time threat.
How did a Native South Dakotan wind up leading a Swiss Research Team?
A South Dakota native from Brookings, Prof. Lee Ann Applegate-Laurent was then and is now is a key leader in the Swiss Consortium Partnership that created the Swiss Army Mass Burn Casualty system and supporting technologies. Not only is Prof Applegate from South Dakota, she also spent a number of pleasant summers at a Methodist church camp very near Hot Springs as a child. She is now the owner of Elanix LLC.
Her studies at the University of South Dakota School of Veterinary Medicine taught her research lab techniques that were so outstanding that she traveled to Switzerland for post-doctoral study. While there she met her future husband and stayed. That began her long research career at the University Hospital at Lausanne, Switzerland.
What was learned from the Swiss Army technology development?
Study of the development reveals that the technology has huge applications in the civilian world as well as on the battlefield. Over 20 successful European compassionate use tests were conducted of the regenerative technology. A compassionate use test is an experimental test of a medical product or invention that has not been approved, but is used because the patient will almost certainly die. In one compassionate use test, a man who was burned over 92% of his body recovered fully and is now running marathons and competing in bike races.
I’d like to know bit more about regenerative medicine. How is it unique?
The pivotal Elanix technology for this proposal is the separation, classification and use of progenitor cells, as well as storage and growth systems for the cells. The regenerative medical science invented by the Swiss is far ahead of the US, especially in burn regeneration research. Besides skin regeneration techniques, they have also expanded their research to regeneration of bone, muscle and cartilage and have actually perfected some additional progenitor cell lines dealing with these kind of cells.
Pre-clinical research has been conducted and completed at the University Hospital at Lausanne, the University Hospital at Zurich, as well as several other Swiss Institutions. In this proposal, technology transfer of regenerative medicine knowledge and skills will be conducted so that a core of practicing experts will reside in Hot Springs, South Dakota.
As the core Hot Springs group develops, clinical research will be moved incrementally to South Dakota from Switzerland. The South Dakota location offers the private company a US base as well as national connections through the Veterans Administration. Hot Springs also has warm mineralized springs used in the convalescence after application of progenitor cell therapy. The clinical site will be the springboard for technology transfer to the United States. Activities will be coordinated by VNRC, which will have its main operating office in Hot Springs.
Why start with skin regeneration and burns?
The VA has a special interest in burns as burn injuries constitute about 5% of all US war casualties from the 911 wars. The VA sits on the Armed Forces Institute for Regenerative Medicine (AFIRM), and has a representative on the Burns Committee. While Brooke Army Medical Center handles burn cases nationally for service members, the VA has no such equivalent specialty body. The confluences of forces and circumstances here provide such an opportunity.
What about blast wounds, TBI and PTSD?
Blast wounds present challenges with limb, genital and maxio-facial reconstruction. Recent Elanix discoveries make it possible to move into these areas. TBI and PTSD are usually present with burn and blast wounds. The hydrotherapy that is used for skin regeneration will definitely have application for Traumatic Brain Injury (TBI). It may also have a role in PTSD therapy because of its soothing effects.
This is very advanced research. What is involved?
Over 30 years of Swiss experience by the Swiss Consortium Partnership (SCP) has been invested in learning how to grow skin cells on burn patients. Because of this, VNRC, through a private sector firm and through SCP has access to techniques that can enhance patient cell growth and result in better healing than US technologies.
In the skin regeneration process, progenitor cells from the original stem cell line are grown and maintained through a proprietary process. When the progenitor cells are applied in layers to the patient’s outer surface (where there is no skin due to injury), they trigger stem cells resident in the patient’s body. Essentially, these resident stem cells are commanded to grow as new skin via commands from the progenitor cells. At the end of the process, the progenitor cells die and all that is left is new skin. This new skin has no scarring or other anomaly. It is sufficiently complete to function as a skin organ in terms of protection and excretion of sweat and human waste.
What are the problems with animal-based stem cell development?
Because of the structure of federal research legislation, non-human species (usually mice) are used for stem cell research in the United States. Many characteristics of animal embryonic stem cell-like cells mimic human embryonic stem cells. However, they are different than those found in humans, and this causes problems in application. Some of the problems include:
- Surface markers on the cell used to identify different aspects of the cell are different. This often causes confusion. Because very minute decisions that are made in the lab, and because on the surface, differences can be very subtle. This can cause dangerous error.
- Growth factor requirements, both in terms of comparable speed to human growth and life cycle as well as cell nurturing, are often asynchronous. When used in conjunction with the human body, this can create auto-immune rejection.
- The ability to differentiate between tissues to be triggered by progenitor cells can be limited. This is because many nuanceful differences in human tissue do not match the nuanceful differences in tissue of the animal subject.
- Auto-immune responses generally have to be dealt with separately, and planned for at every step of the medical process.
- The possibility of migration of non-human genetic code to humans cannot be discounted. Mutation can be triggered by outside forces, such as auto-immune drugs. This limits applicability, especially for pregnant mothers and children.
What are the consequences of the rejection of animal-based fetal cell research by Swiss and the European Union researchers?
The progenitor stem cell lines used in the Medical Miracle proposal are from a single line created and registered in 2008. The cell line to be used in this research was developed outside of the United States under very strict European and Swiss transplantation laws with the safety of the patient as the utmost goal.
Because of its history of development, auto-immune complications are not an issue and do not need to be planned for. With that comes smoother, cleaner surgeries and less complicated convalescences. Growth factors between the subject stem cells and the human body are smoothly synchronized. Cell nutrition is not an issue because it automatically synchronizes to the human condition. There is no risk of trans-species migration of genetic materials.
Who do I contact if I have more questions concerning this proposal
Veterans National Recovery Center, Inc.
PO Box 12007
Des Moines, Iowa 50312.
Email : email@example.com
Telephone : 515-657-0069