21st Century Medicine --Expanding the Boundaries of Preservation Science

Partnership. Performance. Success.

In spite of the amazing progress in transplant medicine over the past generation, serious problems remain. The availability of vital organs for transplant is severely limited, in part, because the systems most commonly used to preserve living tissue are based on 50-60 year old technologies and remain limited in their usefulness. As a result, organ banks do not have the true capability of storing organs for any significant length of time.

And that’s what we want to help change. The preservation solutions and delivery systems under development at 21st Century Medicine may actually improve the health and viability of complex biological systems far beyond the current standard and allow for the possibility of true organ banking.

We’re looking to partner with laboratories, biotechnology companies, and institutions that are also committed to advancing the vision of true organ banking. Our scientific team has unique knowledge in cellular biochemistry and in applying proprietary innovations to the preservation of cells, organized tissue, bio-engineered tissue products and organs.

Bring the goal of successful organ banking within reach. Contact us toll-free at 866-889-1215.

Solving the Organ Banking Challenge

Right now, even if organ banks could eliminate most of the problems of matching organs to recipients to reduce rejection, transporting the organs to where they need to go, scheduling surgery at a time and a place that is best for both the patient and the transplant surgeon, and even preconditioning the recipient to avoid rejection altogether, there aren’t enough organs to meet the demand.

To some extent, this need is being met by tissue engineering companies, which are using their multi-billion dollar investment capital to learn how to build replacement tissues and organs in the laboratory. In addition, other companies are striving to create organs grown from stem cells derived from the same patient who needs the organs. All of these efforts, however, will require banking of laboratory-produced tissue replacements because there needs to be some flexibility between the time an organ is produced and the time it is used, and because maintenance of the organ at high temperatures for months or years before use would be both dangerous and prohibitively expensive.

Our cold vitrification techniques utilize low toxicity solutions and optimized cooling and warming curves that, when applied under sterile conditions, allow for better, longer, safer and more convenient storage of complex living systems. Our research offers major benefits to patients in the near term, while serving as a bridge to a positive working relationship between the company and the organ transplant community upon which it ultimately depends.

Filling the Transplant Technology Gap

Right now, about 20,000 organs are transplanted each year in the United States, and an approximately equal number are transplanted in the rest of the world. All of these organs have to be flushed with a preservation solution in order to remove blood and stabilize the organs for the 4-36 hours currently available for organ allocation, transportation, and transplantation.

As a side benefit of our research on the cryogenic banking of organs, we are currently developing a new organ flushing solution that seems to have a number of advantages over the current world leader, known as UW (University of Wisconsin) solution (trade name:  Via span™).

This solution, called Trans Send, seems to performed better because it displaces blood rapidly and easily, and isn't as viscous as UW solution. Also, Trans Send is made from less expensive ingredients and is easier and faster to manufacture than UW solution, which means better consumer protection against spiraling costs. Plus, Trans Send contains only ingredients that are safe for delivery into the human body and therefore, unlike UW solution, there will be no need to flush the solution out of the organ before the organ is transplanted. Finally, of course, there is the all-important observation that the solution seems to be better than UW solution for the actual job of preserving kidneys for periods of 2-4 days in experiments conducted so far involving both rabbit and dog kidney transplants.

We are concurrently developing a different solution and method that is specifically tailored to the preservation of the heart and that has extended the preservation time possible in a dog heart model from the current clinical limit of 4 hours to a remarkable 45 hours and beyond. Both projects have been generously supported by phase II small business innovative research (SBIR) grants from the National Institutes of Health (NIH).

Our scientists have also been able to demonstrate, for the first time, that a sensitive mammalian organ can be cooled to deep subzero temperatures, rewarmed, and transplanted with subsequent life support ability.

Our present model is the rabbit kidney because both the housing and the transplantation procedures for this species are feasible and inexpensive and because more is known about the cryobiology of the rabbit kidney than of any other organ. The road to the cryogenic banking of the rabbit kidney has been a long and difficult one, dating back to the 1970’s. The present approach, which allows us to avoid freezing and thawing altogether even though we cool to more than 200°F below zero, was first conceived of in 1980 at the American Red Cross and is called “vitrification” or glass formation, a glass being a kind of “hard liquid” that is basically too cold to flow.

Since then, the main goal has been to find solutions and methods of use of these solutions that allow vitrification of whole organs without being biologically damaging. Progress between 1980 and 1997 was considerable, but it was really a series of breakthroughs beginning ten years ago, here at 21st Century Medicine that have brought the goal of successful organ banking closer than ever before. These continuing breakthroughs are both basic and applied, the applied successes serving to validate the utility of the basic observations and demonstrate their general applicability.

Cryogenic Organ Banking Getting Closer: Implications Profound for Transplant Patients