Description:
Dr. Kevin Stone is interviewed by Molly McCrae of CBS News 5 regarding
the safety, risks, and benefits of using donated tissue for transplantation
in Orthopaedics. 8:21 minutes/11.5MB |
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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.
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. |
