How long have you been doing knee surgeries?

Since the late 80’s, and we have been doing tissue transplantation since that time as well.

This has gotten a lot of press back East but very little coverage here. We have a patient who has told us that he has been informed by his doctor to get all these tests. Should he be concerned about the origin of his tissues? There are a lot of aging baby boomers who, most likely, will be getting knee surgery in the future.

Tissue transplantation, meaning allograft tissue transplantation, donating tissue from someone who dies to someone who needs the tissue, has been around for a long time. There are three major issues involved in tissue transplantation today that are important for recipients to know. First is that donated tissues are extremely effective at solving a host of problems. In this era when we try to biologically rebuild people’s knees, we want to use natural tissues rather than artificial tissues. Secondly, natural tissues, such as allograft, donated tissues, provide an excellent matrix for us to add stem cells and growth factors to and it is the future of regenerating knees and shoulders the way we do here. Third, the tissues that are donated are regulated by the FDA in the Good Tissue Practices Guidelines and 90% of the tissues that are transplanted are also regulated by the American Association of Tissue Transplant Banks. So, most of the tissues are very safe. Additionally, over the last few years, there have been new sterilization procedures. So, even if a donated tissue might have slipped through some of the screening, most of the new sterilization procedures will treat the infections that might be present in those tissues, not completely and not always, but most of the time.

So let’s say a patient has received an allograft transplant and let’s say that they test positive for one of these infections, then it is just a matter of treating them at that point?

It depends on the infection. Clearly, if they were to test positive for a virus, such as HIV or Hepatitis, those are very difficult to treat and require a long-term treatment and that is the worst-case scenario. Fortunately, all of the tissues that we are able to transplant are tested for those diseases.

You say the vast majority of tissue, which is provided to patients who need it, is safe or that patients need not worry in the vast majority of cases. There is that 10%; what’s going on with that?

The tissue transplant industry has not been regulated as well in the past as the device industry in the United States. The FDA was not as heavily involved. Now they are more involved and now the Association that regulates tissue banks has much more stringent criteria. Unfortunately, when someone dies, it is usually a very short window between their unfortunate death and the time in which their tissues can be transplanted. And the environment in which they die is also, often, not ideal -- for instance, if they have been a patient in a hospital for a long time and had lots of different treatments involved or if they are at a funeral home. These are not the normal, sterile, environments that we would use, as in an operating room. So, today, with new tissue sterilization techniques and careful testing and harvesting, most of the problems can be caught but not every one.

Where do you see room for improvement?

First of all, no patient and no hospital should use tissues that do not come from an AATB, the association – regulated tissue banks, number one. Number two, in most cases, allograft donated tissue, particularly in Orthopaedics, can be sterilized and that should be done whenever possible. Number three, using a well-regarded, well-respected tissue donor source or bank, usually gives the surgeon and the patient a confidence level that the tissues they are using are going to be safe. The future is better sterilization procedures and also the new xenograft or animal-donated tissues that can be sterilized and that start off safe from day one and that is the future of the industry.

Even this company, that is a well-respected company, unfortunately was receiving tissue from a company where there may be problems with how they procure their tissue. How do you, as a surgeon, or how does a patient know that what they’re getting is good?

There is no question that there are still quite a few improvements that can be made on the tissue harvesting side of the tissue banking industry. The sterilization side is improving daily and we, as surgeons, feel more comfortable when we receive a tissue that is sterilized because we know that, even if it has been harvested under difficult conditions, sterilization will hopefully protect us and our patients. That is the best we can do today and, in the future, I think there will be better sterilization methods.

We’re seeing improvements with the sterilization, that’s great but the harvesting; we might need improvement with that?

Clearly the harvesting environment and the regulations around the harvesting, as well as the regulations around the tissue processing can still be improved because there are many tissues that can’t be sterilized. In Orthopaedics, we have had the benefit that we can usually use sterilized tissues but people who need hearts or lungs or organs that are transplanted, often those tissues cannot be sterilized or the tissue would be killed. So there, there needs to be tougher regulations on the harvesting side and improvements on the testing side, which the banks are doing everyday.

Finally, there are non-profit centers and the for-profit center. Especially for the for-profit center, does that create a pressure to procure this tissue at any price because there is such a demand? Because my understanding is that there is a big demand for ligaments, tendons, and skin.

From the surgeon’s side, I think we can only rely on using the best tissue regulation practices, the banks that are part of the AATB, the banks that use sterilization, and the really top level, top tier providers of tissue. We need to rely on their processes to protect our patients and us. We also need to hope that the sterilization and harvesting procedures continue to improve in the future.

Anything else that you want to add?

I think that allograft donated tissues and xenograft tissues from animals are really the future in many things that we do our research in, in Orthopaedics. They are the perfect carriers for growth factors. They are the perfect carriers for stem cells. And we are using them today, in people already, with the patient’s own stem cell to regenerate and rebuild their tissues. So, while we are all very worried about the few cases that pop-up where something slipped through the screening, the donation of tissues is an enormous contribution to everyone who needs them and to the world and medicine in general.

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The Stone Clinic in San Francisco concentrates on returning injured people to their active lives, fitter, faster, and stronger than they were before. The Stone Clinic includes Dr. Kevin Stone, physician and surgeon, a staff of physical therapists, and an x-ray and MRI facility. Our specialties include the treatment of joint injuries and arthritis with leading edge surgical and rehabilitation techniques. Elite athletes and everyday people alike come to The Stone Clinic from around the world for the best in orthopaedic care. The Stone Clinic is located at 3727 Buchanan St., San Francisco, CA 94123. For more information, please call us at (415) 563-3110.