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The world of Regenerative Medicine is racing ahead. Recent innovations in the processing of adipose tissue (fat) have created a new crop of innovators seeking to leverage and commercialize the use of adipose tissue and adipose derived regenerative cells for a host of applications. Many of these innovations are focused on the cosmetic and plastic surgery industries. Companies are marketing cellular preparation kits, fat transfer methods and supplies, as well as services to process tissues and return them to the physician the same day.
With all this activity and the myriad new companies marketing to you, how do you decide what is best for you and your patient? How do you protect your patients while providing them with cutting edge cellular therapies and treatments? How do you assess the efficacy of these treatments? How do you know that you are compliant with current regulations (industry guidance)? Which regulations apply and which do not?
These questions loom large within the industry and its regulators. This is especially true for new products and processes that claim exemption from the regulations. The answers are not always obvious or easy.
In the process of building our company, we have spent years reviewing and interpreting the current regulations with scientists, lawyers and doctors. While there are many factors that impact decision making, we believe that before acting, some basic questions should be asked and answered.
- How is this product or process regulated on the state and federal levels?
- Is there any regulatory guidance that can be reviewed?
- Am I required to have my treatment protocol reviewed by an Institutional Review Board?
- If the product or process is to be used immediately, how can sterility be assured?
- What tests for sterility need to be performed? How and when are the results delivered?
- What is the yield of viable regenerative cells? How are they described?
- What is the actual makeup of the resulting product: i.e. how many fibroblasts, stem cells, adipocytes, osteoblasts, chondrocytes, etc?
- Is the sample free of other contaminants and/or damaged cells?
- What data can be provided to support your position and claims?
- How can the efficacy of the treatment be monitored and assessed?
These questions should be answered by a company that is seeking to provide you with products or services for cellular therapies. They should be able to provide you with guidance and answers that:
- help you be confident and comfortable presenting and explaining the product or service to your patients
- provide you with information so you fully understand the implications of your use of the product or service
- ensure that you have taken every precaution and instituted correct policies and procedures
- ensure the safety of your patient with the use of their product or service
- keep you and your practice operating within the very complicated web of regulation
To learn more about American CryoStem or enroll as an adult stem cell collection service provider, call as us 1-866-519-3554 to speak with a physician support representative. www.americancryostem.com
Angela M. Miele, DPM
Medical Science Liaison
Modern day medicine is quite an amazing thing. Think of the drastic changes in the last fifty years, most notably, in the field of transplant surgery. A life saving procedure which is aided by major advances in anti-rejection medications, transplants have given hope to patients where none existed before. In 2011, the number of patients on the waiting list for transplants is trending higher than last year while the number on the donor list remains flat (UNOS.org). According to the U. S. Department of Health and Human Services, an average of 75 people receive organ transplants each day. Unfortunately, however, an average of 20 people die each day while waiting for transplants that do not happen because of the shortage of donated organs. Every 11 minutes, someone is added to the organ donation waiting list.
Modern medicine and technology (e.g. dialysis, left ventricular assist devices) can keep patients alive longer than was possible fifty years ago, but at what cost? Do these options prolong the hope of a transplant, or accentuate the need for other alternatives?
Organ donations are encouraged in a variety of forms. You can now check a box off on the back of your license plate indicating your willingness to donate your organs should you die in an accident. Living wills allow an individual to direct what organ(s) one would like to donate should you be in a vegetative or non-resuscitable state. Why then, are donations not meeting the current need? Perhaps it is fear of the unknown – there are urban myths, (some heard from patients) – who are concerned that if they have registered as a donor and come to be in a vegetative state, it may hasten a decision leading to their demise. More grass root efforts should be made to raise awareness of organ donation. How many times while in your neighborhood have you seen flyers in a store, for example, asking individuals to get tested as a possible donor for a child or adult who needs a rare bone marrow match or organ transplant? We have the science and technology to perform these complex surgeries, yet thousands die each year in wait. These flyers are a cry for better alternatives, a silent prayer for solutions to unmet needs.
The near-future landscape is ripe to solve this dilemma – an organ created from your own adult stem cells would obviate the need for a donor. It may seem that I am getting ahead of myself, but this scenario is not that far-off. Consider Dr. Anthony Atala, Director of Regenerative Medicine at Wake Forest University, North Carolina. He has already grown human bladders from stem cells taken from the patient and transplanted. All of the recipients are doing well five years later. In addition, he and his team are also “growing” heart valves, muscle, and fingers for future transplantation. He is one of many scientists/clinicians around the world dedicated to tissue engineering using adult stem cells. Those of us who keep tabs on Regenerative Medicine are acutely aware of how close this is, that the finish line is in sight. More studies need to be performed on larger scales, yes, but adult stem cells are providing hope. While not the panacea for all transplant needs, adult stem cells can certainly increase the number of survivors on the waiting list. Even if it is by one, it is a victory against death.
Currently, autologous adult stem cell treatments are being investigated and are showing great promise in many applications; in the very near future one can theoretically heal oneself. There are also early clinical trials showing that adipose derived stem cells may be used for allogeneic transplants. While these are a little further off, they are still plausible. Adult stem cells can now be banked for future therapies as well as current applications should the need arise. This limbo that exists, this game of chance, may have resolution before the end of the decade.
So, for now, we are in a holding pattern – waiting, hoping, anticipating a time when we can tell our patients that the cure for their ailment lies within them.
Angela M. Miele, DPM
Medical Science Liaison
Juan Ponce de Leon is best known for his search for the fountain of youth. Though this story is probably more fiction than fact, and was attributed to him only after his death, the legend of the fountain of youth and the quest for it have persisted since the 16th century. It has proven to be as elusive as the Holy Grail.
I hear a lot of baby boomers (of which I am one) talk about aging and the quest to maintain their youthful look, mind and health. If only there was a magic elixir for the myriad problems we face in our advancing age. Well, perhaps there is something that can turn back the hands of time to some extent, a little bit of the fountain of youth if you will.
Adipose tissue has been found to be an easily accessible, abundant source of adult stem cells. These stem cells can be used to treat a broad range of medical and cosmetic conditions. If you look at our Resource Library, you’ll see a sampling of the potential applications of adipose derived stem cells, from growing new bone to aiding reconstructive procedures to mitigating the symptoms of multiple sclerosis. And, yes, adipose derived stem cells can help us look youthful too. You can have lipofilling and lipostructuring performed anywhere on your body. Isn’t this a dream come true? Take your fat from a place you don’t want it and put it somewhere you do! Who of us wouldn’t like to remove a few pounds of avoir du pois and apply it elsewhere?
All joking aside, the potential future medical applications for adipose derived stem cells are profound, and they are not that far off. Now is the dawn of the era of regenerative and personalized medicine. Most countries outside of the United States are already using adult stem cells to treat patients with myocardial infarctions, fistulizing Crohn’s disease, and to grow organs. Medical tourism, traveling to other countries to take advantage of treatments not yet routinely available in the United States, has become a booming industry in part because of regenerative and personalized medicine. It is only a matter of time before these therapies become available in the U.S.
So this brings to mind a question. What can I do now to prepare? Speaking for myself, I already have an answer. I will store my adult stem cells in the hope of using them later in the event of a medical ailment, or, in a more vain moment, when I want to reverse the visible “hands of time” with a cosmetic treatment. Not only will I store my own adult stem cells, but I will encourage my children to store theirs as well. After all, that one umbilical cord blood sample I keep may not be useful for all three of them, so why leave anything to chance? It is a bio-insurance that will give me some peace of mind as a mother. It is also a gift I will be giving to family and loved ones. What about you?
Angela M. Miele, DPM
Medical Science Liaison