US Stem Cell Inc (USRM)

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FDA - KRISTIN COMELLA TRANSCRIPT

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DR. WITTEN: Our next speaker represents
U.S. Stem Cell Inc.
DR. COMELLA: Thank you. I'm Kristin
Comella. I'm the chief science officer of U.S.
Stem Cell. We are a publicly traded company, so I
must remind you of the forward-looking statements.
We have a comprehensive mix of products. We've
been a company since 1999, and our focus has
always been to bring stem cell therapies to
patients.
I think this quote is particularly
important today. All truth passes through three
stages. First, it's ridiculed. Second, it's
violently opposed. And third, is it accepted as
being self-evident?
The re-implantation of autologous HCT/Ps
is recognized in the regulations and during the
same surgical procedure, this is considered the
practice of medicine. And there are a variety of
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different things that are recognized under this,
including fat grafts, skin graft, bone marrow
transplants, platelet rich plasma, tendon and
ligament grafts, vascular grafts, hair grafts, and
bone grafts. All of these procedures are
considered surgical and they did not go through
double-blind, placebo-controlled trials.
I want to focus on the comparison
between bone marrow and fat tissue, and, in
particular, something called stromal vascular
fraction that a lot of people have been discussing
today. The reason that bone marrow is accepted
under a 510K is because there was preexisting
technology to the 1976 amendments covering medical
devices. Fat tissue does not have that same
luxury because there was no preexisting
technology. But why would fat and bone marrow be
viewed separately? When you're taking cells from
bone marrow, why is this different than taking
cells from fat? And in particular, fat is a less
invasive method of collecting and also isolating
the cells with lower risks associated with it.
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In addition, there are higher numbers of
cells and stem cells and lower numbers of white
blood cells which are inflammation creating in the
fat tissue versus the bone marrow. So
scientifically speaking, it makes zero sense that
we'd regulate these two tissues in a different
manner. Why would the FDA regulate our own body
tissue and consider this a drug?
Who is responsible for paying for these
trials if the FDA doesn't do it? Pharmaceutical
companies typically cover the expenses associated
with doing a double-blind, placebo-controlled
trial. Because there is no drug to sell at the
end of this because it's cells from your own body,
no pharmaceutical company is going to cover these
trials, so who is going to cover these trials if
they're going to be mandated by the FDA?
In addition, why would the FDA regulate
cells from bone marrow and fat tissue different?
These are some images from our clinic where we
treat patients. These are our medical
practitioners who care very much about their
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patients, and their safety and outcomes, and who
have become, in some sense, disgusted with the
medical system and some of the products that are
currently available that are not making patients
better. We need new options for patients.
The process is very simple. It can be
done in under 60 minutes. A small sample of fat
tissue is taken in a minimally manipulated process
where the patient remains awake. There is no
general anesthesia. The cells are obtained and
can be administered back to that same patient.
We've trained over 600 practitioners
throughout the world and in the U.S. who are doing
these procedures safely. We have over 6,000 cases
documented and when you consider some of our
colleagues, there are tens of thousands of cases
documented. If this was really a safety concern,
there would be more than a handful of adverse
events which are being reported. And that's all
we have right now, just a handful out of ten
thousands of patients. And there is no drug on
the planet that has that kind of record.
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Regenerative medicine is here to stay
and it's continuously growing. We, as a field,
have an obligation to bring these therapies
forward. Patients have a right to make an
informed consent decision about how they're going
to use these treatments on themselves. They have
a right to alternative therapies. We need more
funding for these patient trials and the
government should not regulate all bodies. I'm
Kristin Comella and I will always stand up for
patient rights. Thank you. (Applause)