April 13, 2024 • 9 mins
A TEAM OF SCIENTISTS HAVE LAUNCHED THE FIRST HUMAN TRIAL IN AN ATTEMPT TO GROW A NEW LIVER INSIDE OF A HUMAN USING LYMPH NODES, WHICH COULD TRANSFORM ORGAN DONATION IF SUCCESSFUL. WE SPEAK WITH DR. MICHAEL HUFFORD, CEO OF LYGENESIS, A PITTSBURGH-BASED BIOTECH COMPANY BEHIND THE RESEARCH.
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Episode Transcript
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(00:00):
Welcome to American Medicine Today, presentedby the Benati Spine Institute, featuring internationally
acclaimed inventor of the Benati spine procedures, Alfred Benatti, MDI here your host,
Kimberly Bermel Benati and co host EthanUcker. Welcome to American Medicine Today.
I'm Kimberly Benati alongside Ethan Yucker andworld renowned orthpedic surgeon doctor Alfred Benatti.
(00:22):
So, a team of scientists havelaunched the first human trial in an
attempt to grow a new liver insideof a human using lymph nodes, and
this could really transform organ donation ifsuccessful. Joining us to discuss is doctor
Michael Hufford, CEO of lie Genesis, a Pittsburgh based biotech company behind the
research. So, first off,thank you for joining us, doctor Hufford,
(00:46):
Well, thank you so much forhaving me. I really appreciate your
interest certainly, and it almost soundslike science fiction. I mean, how
really do you turn liver cells froma living donor into an actual functioning liver
for a patient using lymph nodes.We are living in a remarkable time when
it comes to biomedicine and innovation.And genesis. We're leveraging a lot of
(01:08):
natural biology. So all of uswalk around with five hundred lymph nodes spread
throughout our body. Those naturally helpus fight off infection. So when you
get a cold, you might feelthat they enlarge, and that's those lymph
nodes creating T cells to help youfight infection. We're using that same biology,
but now we're in grafting our cellulartherapy into the lymph node, which
(01:30):
remarkably, over time those cells willovertake the lymph node and become a functioning
act topic organ that we've demonstrated inour preclinical studies are capable of rescuing animals
from otherwise fatal liver disease. Sowe're hoping to do that same thing in
patients within stage liver disease now,and I understand that basically this technique has
(01:53):
been around for like a decade,is that correct? That's correct. It
was originally discovered by my chief scienceOfficer, doctor Eric lagat Us, who's
also a co founder of Ligenesis.Doctor Lagas works at the McGowan Institute for
Regenerative Medicine here at the University ofPittsburgh. He was the one who initially
discovered that you could use the lymphnode to bioreact these various different tissue in
(02:14):
organ types, the liver being themost advanced. But he's also shown the
same principle holds for the development ofan ectopic kidney for patients with in stage
renal disease and ectopic pancreas for patientswith type one diabetes, as well as
an ectopic finmus that has important andexciting implications for aging as well. But
this case that we do with thelymph node and deliver, how the lymphoode
(02:38):
will increase in size or will itjust become active as small that's a great
question. So what we've shown inat least the pre clinical studies to date
is when you engraft these hepatocites orliver cells into these lymph nodes, first
they start to organize themselves and theyform the various stituent parts that form a
(03:00):
liver. Over time, the lymphodewill actually disappear and what you're left with
will be this ectopic liver. Thesize of that liver is determined by the
severity of the liver disease, butit's certainly the case. For instance,
in liver transplant. When you goto transplant a patient, very often the
lymph nodes adjacent to the liver caneven be the size of your fist.
(03:23):
So very often in in stage liverdisease, the liver is shrunk, it's
become fibrotic, and one of thethings that often takes up the space in
the GOT tends to be these enlargedlymph nodes which were now trying to leverage
for more of a therapeutic effect.And why that happens that the lymphanode doesn't
behave like a liver again you followingwhat a MASKI You said that these lymphanodes
(03:46):
become bigger when you have delivered disease, and you tell me also that the
lymphanol will increase in size. Butwhen that happens on that limphoode that is
already big in site trying to savebecause they incompat and liver, why doesn't
that lymph node already replace the liverin that patient that their own lympho noode.
(04:10):
Sure, yeah, you know,in in stage liver disease, those
lymph nodes are really responding to theinflammation and fibrosis of the diseased liver,
so they're really serving no therapeutic function. By engrafting the hepatocites into the lymph
node, those those liver cells detectthe diseased liver. So, as you
know, each disease liver is actuallyemanating dozens of pro growth factors. The
(04:32):
liver naturally does try to regenerate itself, but an in stage liver disease is
unable to do so. So whatwe do by ingrafting our cell therapy into
the lymph nodes of these patients.Those cells are then exposed to those pro
growth signals respond by organizing themselves intothese ectopic livers that then vascularize and help
(04:54):
to filter the patient's blood, whichhopefully will help with their in stage liver
disease. And can you inject thoseliver cells directly on the large lympho node
or it's already too damage by theinfection or the damage that half bay it
self. That's a great question.So one of the innovations that like genesis,
(05:15):
is we use an outpatient indoscopic ultrasoundprocedure to ingraft ourselves. So we're
going down through the mouth of thepatient and then imaging lymph nodes adjacent to
the gut wall, and then weinject our cell therapy into those lymph nodes.
The benefit of that, of course, is that it's an outpatient procedure
done under light sedation for patients withinstage liver disease. Up to fifty percent
(05:40):
of them don't even qualify to makethe transplant list because they're simply too ill
and won't survive the procedure. Soone of the things we're excited about is
we're really giving an option for thosepatients that otherwise would not even be eligible
to make the liver transplant weight listbecause we're using a route of ingraphment of
our cell therapy that is such lowmedical risk that way, that is incredible.
(06:02):
Let me ask you one more questionthat's tickling my brain right now.
What do you get the cells?Those cells are the same cells of the
sick liver that you're using or fromwhat are you getting the liver cells?
Yeah, you no, great question. So we're using donated but unmatched organs.
So here in the US about aquarter of donated livers are not matched
(06:25):
for transplant, but they've been screenedand found to be safe and are ready
to go. So what we're doingis we're taking some of those donated livers
that are otherwise unmatched for transplant.We use those as the source of cells.
And part of the beauty of thatis, as you know, today
one donated organ treats just one patient. Using our approach, one donated liver
(06:45):
can treat up to seventy five patients. So it's really upending the supply demand
ratio when you think of organ donationthat way. But you can you can
go ahead and get the liver cellson the early stage of degeneration is start
to see the nodes. Yeah,So we're taking otherwise healthy livers that have
(07:09):
been donated for transplant but unmatched,and we process those livers through a procedure
that results in our in our celltherapy and then transplanted into patients. So
they have to be blood type matchedand they will be on immune suppression.
We hope eventually to be able toavoid that with future versions of our therapy,
but today they'll be on immune suppression. Okay, my question still is
(07:31):
this, if you have a liverthat is regenerating partially when they in the
initial stage of the failure for theliver, then you can take those cells that
they are trying to regenerate and yetand then you don't have the problem on
try to do cells that they canbe not suitable for the transplant and use
(07:54):
those cells directly to the lymphonodes.Yeah. No, that's a great question.
So we have considered that typically anin stage liver disease, and what
my liver transplant colleagues tell me isthat because the liver so fibroduct, even
touching it can lead to really potentiallycatastrophic bleeding. So the risk of going
in and trying to sample cells fromthe disease liver doesn't really outweigh the from
(08:18):
a risk benefit perspective that procedure.So for now we're relying on these donated
organs. Okay, right, onelast quick question, doctor Hufford. When
do you see this actually being availablefor the public, Like when you know,
once you're past the trials and it'sactually being implemented. Yeah, you
know, drug development takes longer thanany of us would like. This trial
(08:39):
will likely last for the next twentymonths or so. We'll have to run
at least one more trial after that. If all that goes well, then
in an ideal scenario in the nextfour to five years. This therapy,
if shown to be safe and effectiveand if FDA approved, could eventually be
available to folks. But we areseveral years out from that yet. And
where can they learn more? Theycan learn more if you visit either our
(09:03):
website at www dot like Genesis dotcom, or also our clinical trials also
listed on Clinicaltrials dot gov, whichis a great resource for patients trying to
learn more about experimental therapies. Well, thank you so much, doctor Michael
Hufford for being on the program.It's my pleasure. Thank you. Thank
you keep us updated on the progresswe'll do. Coming up after the break,
(09:24):
we'll have more. You're listening toAmerican Medicine Today.
Welcome to American Medicine Today, presentedby the Benati Spine Institute, featuring internationally
acclaimed inventor of the Benati spine procedures, Alfred Benatti, MDI here your host,
Kimberly Bermel Benati and co host EthanUcker. Welcome to American Medicine Today.
I'm Kimberly Benati alongside Ethan Yucker andworld renowned orthpedic surgeon doctor Alfred Benatti.
(00:22):
So, a team of scientists havelaunched the first human trial in an
attempt to grow a new liver insideof a human using lymph nodes, and
this could really transform organ donation ifsuccessful. Joining us to discuss is doctor
Michael Hufford, CEO of lie Genesis, a Pittsburgh based biotech company behind the
research. So, first off,thank you for joining us, doctor Hufford,
(00:46):
Well, thank you so much forhaving me. I really appreciate your
interest certainly, and it almost soundslike science fiction. I mean, how
really do you turn liver cells froma living donor into an actual functioning liver
for a patient using lymph nodes.We are living in a remarkable time when
it comes to biomedicine and innovation.And genesis. We're leveraging a lot of
(01:08):
natural biology. So all of uswalk around with five hundred lymph nodes spread
throughout our body. Those naturally helpus fight off infection. So when you
get a cold, you might feelthat they enlarge, and that's those lymph
nodes creating T cells to help youfight infection. We're using that same biology,
but now we're in grafting our cellulartherapy into the lymph node, which
(01:30):
remarkably, over time those cells willovertake the lymph node and become a functioning
act topic organ that we've demonstrated inour preclinical studies are capable of rescuing animals
from otherwise fatal liver disease. Sowe're hoping to do that same thing in
patients within stage liver disease now,and I understand that basically this technique has
(01:53):
been around for like a decade,is that correct? That's correct. It
was originally discovered by my chief scienceOfficer, doctor Eric lagat Us, who's
also a co founder of Ligenesis.Doctor Lagas works at the McGowan Institute for
Regenerative Medicine here at the University ofPittsburgh. He was the one who initially
discovered that you could use the lymphnode to bioreact these various different tissue in
(02:14):
organ types, the liver being themost advanced. But he's also shown the
same principle holds for the development ofan ectopic kidney for patients with in stage
renal disease and ectopic pancreas for patientswith type one diabetes, as well as
an ectopic finmus that has important andexciting implications for aging as well. But
this case that we do with thelymph node and deliver, how the lymphoode
(02:38):
will increase in size or will itjust become active as small that's a great
question. So what we've shown inat least the pre clinical studies to date
is when you engraft these hepatocites orliver cells into these lymph nodes, first
they start to organize themselves and theyform the various stituent parts that form a
(03:00):
liver. Over time, the lymphodewill actually disappear and what you're left with
will be this ectopic liver. Thesize of that liver is determined by the
severity of the liver disease, butit's certainly the case. For instance,
in liver transplant. When you goto transplant a patient, very often the
lymph nodes adjacent to the liver caneven be the size of your fist.
(03:23):
So very often in in stage liverdisease, the liver is shrunk, it's
become fibrotic, and one of thethings that often takes up the space in
the GOT tends to be these enlargedlymph nodes which were now trying to leverage
for more of a therapeutic effect.And why that happens that the lymphanode doesn't
behave like a liver again you followingwhat a MASKI You said that these lymphanodes
(03:46):
become bigger when you have delivered disease, and you tell me also that the
lymphanol will increase in size. Butwhen that happens on that limphoode that is
already big in site trying to savebecause they incompat and liver, why doesn't
that lymph node already replace the liverin that patient that their own lympho noode.
(04:10):
Sure, yeah, you know,in in stage liver disease, those
lymph nodes are really responding to theinflammation and fibrosis of the diseased liver,
so they're really serving no therapeutic function. By engrafting the hepatocites into the lymph
node, those those liver cells detectthe diseased liver. So, as you
know, each disease liver is actuallyemanating dozens of pro growth factors. The
(04:32):
liver naturally does try to regenerate itself, but an in stage liver disease is
unable to do so. So whatwe do by ingrafting our cell therapy into
the lymph nodes of these patients.Those cells are then exposed to those pro
growth signals respond by organizing themselves intothese ectopic livers that then vascularize and help
(04:54):
to filter the patient's blood, whichhopefully will help with their in stage liver
disease. And can you inject thoseliver cells directly on the large lympho node
or it's already too damage by theinfection or the damage that half bay it
self. That's a great question.So one of the innovations that like genesis,
(05:15):
is we use an outpatient indoscopic ultrasoundprocedure to ingraft ourselves. So we're
going down through the mouth of thepatient and then imaging lymph nodes adjacent to
the gut wall, and then weinject our cell therapy into those lymph nodes.
The benefit of that, of course, is that it's an outpatient procedure
done under light sedation for patients withinstage liver disease. Up to fifty percent
(05:40):
of them don't even qualify to makethe transplant list because they're simply too ill
and won't survive the procedure. Soone of the things we're excited about is
we're really giving an option for thosepatients that otherwise would not even be eligible
to make the liver transplant weight listbecause we're using a route of ingraphment of
our cell therapy that is such lowmedical risk that way, that is incredible.
(06:02):
Let me ask you one more questionthat's tickling my brain right now.
What do you get the cells?Those cells are the same cells of the
sick liver that you're using or fromwhat are you getting the liver cells?
Yeah, you no, great question. So we're using donated but unmatched organs.
So here in the US about aquarter of donated livers are not matched
(06:25):
for transplant, but they've been screenedand found to be safe and are ready
to go. So what we're doingis we're taking some of those donated livers
that are otherwise unmatched for transplant.We use those as the source of cells.
And part of the beauty of thatis, as you know, today
one donated organ treats just one patient. Using our approach, one donated liver
(06:45):
can treat up to seventy five patients. So it's really upending the supply demand
ratio when you think of organ donationthat way. But you can you can
go ahead and get the liver cellson the early stage of degeneration is start
to see the nodes. Yeah,So we're taking otherwise healthy livers that have
(07:09):
been donated for transplant but unmatched,and we process those livers through a procedure
that results in our in our celltherapy and then transplanted into patients. So
they have to be blood type matchedand they will be on immune suppression.
We hope eventually to be able toavoid that with future versions of our therapy,
but today they'll be on immune suppression. Okay, my question still is
(07:31):
this, if you have a liverthat is regenerating partially when they in the
initial stage of the failure for theliver, then you can take those cells that
they are trying to regenerate and yetand then you don't have the problem on
try to do cells that they canbe not suitable for the transplant and use
(07:54):
those cells directly to the lymphonodes.Yeah. No, that's a great question.
So we have considered that typically anin stage liver disease, and what
my liver transplant colleagues tell me isthat because the liver so fibroduct, even
touching it can lead to really potentiallycatastrophic bleeding. So the risk of going
in and trying to sample cells fromthe disease liver doesn't really outweigh the from
(08:18):
a risk benefit perspective that procedure.So for now we're relying on these donated
organs. Okay, right, onelast quick question, doctor Hufford. When
do you see this actually being availablefor the public, Like when you know,
once you're past the trials and it'sactually being implemented. Yeah, you
know, drug development takes longer thanany of us would like. This trial
(08:39):
will likely last for the next twentymonths or so. We'll have to run
at least one more trial after that. If all that goes well, then
in an ideal scenario in the nextfour to five years. This therapy,
if shown to be safe and effectiveand if FDA approved, could eventually be
available to folks. But we areseveral years out from that yet. And
where can they learn more? Theycan learn more if you visit either our
(09:03):
website at www dot like Genesis dotcom, or also our clinical trials also
listed on Clinicaltrials dot gov, whichis a great resource for patients trying to
learn more about experimental therapies. Well, thank you so much, doctor Michael
Hufford for being on the program.It's my pleasure. Thank you. Thank
you keep us updated on the progresswe'll do. Coming up after the break,
(09:24):
we'll have more. You're listening toAmerican Medicine Today.
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