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March 28, 2020 - Rudy Giuliani
26:45
Prominent Medical Expert Discusses Stem Cell Therapy with Mayor Rudy Giuliani
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It's our purpose to bring to bear the principle of common sense and rational discussion to the issues of our day.
America was created at a time of great turmoil, tremendous disagreements, anger, hatred.
There was a book written in 1776 that guided much of the discipline of thinking that brought us to the discovery of our freedoms, of our God-given freedoms.
It was Thomas Paine's Common Sense, written in 1776, one of the first American bestsellers in which Thomas Paine explained by rational principles the reason why these small colonies felt the necessity to separate from the powerful Kingdom of England and the King of England.
He explained their inherent desire for liberty, freedom, freedom of religion, freedom of speech, and he explained it in ways that were understandable to the people, to all of the people.
A great deal of the reason for America's constant ability to self-improve is because we are able to reason, we're able to talk to each other, we're able to listen to each other, and we're able to analyze.
We are able to apply our God-given common sense.
So let's do it.
Hello, this is Rudy Giuliani and I'm back with Rudy Giuliani's Common Sense.
And today's episode is going to be devoted to the killer, the war, whatever you want to call it, the attack on humanity by this new viral agent.
It's a terrible, terrible thing.
We have the world in lockdown, and it's this little viral thing that's doing it to us.
Of course, we half understand it, but today I have with me someone who understands it 100% and is in the forefront of trying to find cures for us.
And all we can do is wish him the best of luck and pray for him.
But he's a great doctor.
His name is Robert Harari.
He was trained, of course, in New York, where many of our great doctors are trained from.
Excuse the parochial pride.
And he was trained at or spent most of his time at Weill Cornell.
And since then he's developed this emphasis on cell therapy for many, many years, and he'll explain it better to you how it relates to what we're doing.
But this is Robert Harari, doctor, professor, teacher, and someone who was a brain surgeon.
Which put him in the field of neuroscience and gave him a real overview of how this all works.
So tell us, right to the point, you have a therapy that you believe could be effective.
In attacking this novel coronavirus, which we call COVID-19.
Please explain it to me as best as we can understand it.
And you do a great job of making it understandable to us and our doctors.
You really do.
We've talked for some time.
Well, first of all, thanks so much for having me.
It's great to see you.
You and I have spoken about this and I think the world understands that this is a very unusual crisis we are facing because although viral illnesses are not uncommon, a virus with the characteristics that COVID-19 virus has are a threat because Patients can be exposed and walk around with it for some time while they're infecting others, and there is a percentage of patients who will become quite sick, although the vast majority will not become sick.
Those who become quite sick require quite a bit of medical care, and we didn't, at the time of discovery, recognize that there were a lot of therapeutic options available to us.
So, you know, the field that I've been in for the last 20-25 years is cellular medicine, where we use living cells as medicines to exert a variety of effects, either to control the immune system or to stimulate repair, what we call regeneration.
I've been very fortunate.
The company I started when I left the Cornell Medical Center to get into the field of cellular medicine became a pioneer in developing cell products from the leftovers... And the name of it was?
The name of the company today is Cellularity.
We are a spin-off of a biotech giant called Cellgene.
And Cellgene got interested in cellular medicine very early and in essence cultivated the world's largest cellular medicine and what we call functional regeneration business.
So cell therapy, just to get to the point, is cell therapy is used quite frequently now for attacking various forms of cancer, right?
That's right.
And it's used for For joints and for inflammation.
For example, I am considering doing it for my knees that have lost all their cartilage.
And I've actually seriously considered having an injection.
It's been recommended to me by Mariano Rivera, by my son who's a professional golfer, by other athletes who've had very, very good results.
Mariano's shoulder.
Very good results on his shoulder and I think Tiger Woods knee.
That's right.
Cellular medicine is growing in popularity for degenerative diseases like joint disease.
So I have very little cartilage.
Inject it.
Hopefully it regenerates some cartilage growth and some healthy tissue growth.
Therefore I can avoid a knee replacement.
A good way of thinking about it is that stem cells that can be recovered from various sources, we think the best source is the leftover placenta.
Stem cells are nature's repair kit.
Your body tries to mount a response to any injury by mobilizing and trafficking stem cells to the injury site.
And in healthy young people, those injuries are repaired virtually perfectly.
In older patients and in patients who have other diseases, the quality and number of those cells declines, and the repair and the response declines as well.
Exactly.
therapy where they take your blood and spin it, this is taken from the blood
that you extract from the placenta. Exactly. So early on, you know, I
recognized and my team recognized for cellular medicine to become a part of
mainstream health care, somebody had to create a product.
The product had to be like a pharmaceutical.
It had to be a very high quality, had to be a very high consistency, had to be very scalable so that you could treat many, many patients, and it had to be economically viable to fit into our health care system.
And so up until now, or pretty much now, you've been focusing on cancer.
So tell me, does it meet what you just said?
Scalable, Does it meet all that criteria for cancer?
Absolutely.
So the placenta is an abundantly available raw material.
Every birth.
Right?
Every birth produces this waste material.
And we just happen to have figured out a way to procure these placentas under very high quality, control their processing, and manufacture large quantities of cells from every donor.
So that means that we can meet the scale of a pharmaceutical.
Now there's a certain cell called the killer, natural killer cell, That is relevant here.
You've done several trials on cancer, phase one under the FDA.
They've proven to be effective enough so that FDA now has approved you to go on to stage two and you're beginning those tests.
Right.
So it looks pretty good from the point of view of cancer.
Myeloma you're treating?
That's right.
And you're treating leukemia?
Correct.
And you're also going to start treating solid tumors.
Correct.
But that's in phase two, and it looks, you would say, promising.
We're very excited about it because the bottom line here is that these cells, these natural killer cells, which are part of the innate immune system resident in the placenta, So the relevant question about your cancer research up to this point is, first, it's been approved.
And what a natural killer cell does is it's pre-programmed, if you will, to specifically identify threats to your
health.
In a fetus and in a newborn, they are there to defend the developing fetus from cancer and from infectious diseases.
So the relevant question about your cancer research up to this point is, first, it's been approved.
Secondly, in the testing you've done, has this shown any dangerous side effects?
So we would have to be worried about using it in this particular circumstance.
You know, cellular therapy in general is quite safe.
Right.
But I want to hear that from you.
That's right.
And the reality is, like the infusion of any product into a patient, there are minimal, what we call adverse effects.
Some people get some irritation in the infusion site.
Some people have a mild fever or headache afterwards.
But in general, cellular therapy of the type we're talking about is quite safe.
And we control for that by controlling the quality of the product and the dose and so on.
So, you have applied now to use this therapy to attack COVID-19.
So, what we found early on, the genesis of our work was that the placenta is a defense system against those diseases.
It turns out that natural killer cells from the placenta Can can specifically identify and target
Fascinating.
that are expressed on the surface of cancer cells and virally infected cells.
Those molecules are called stress antigens.
Now, when a natural killer cell sees that stress antigen, it specifically targets that cell for destruction.
And the way it does it is very surgically precise.
It's very surgically precise.
The natural killer cell releases its own chemicals that punch holes in the target cell.
And so we immediately saw that there was an opportunity to take.
How did you see this?
It's well known... When you say you saw it, here you are working on cancer.
The same process works with cancer.
The cancer cells emit this molecule.
Correct.
The killer cell is attracted to that molecule.
Correct.
And in essence attacks it.
That's right.
And punches holes in it.
Exactly.
And we actually can see that.
And kills it.
That's right.
The same way radiation would have done that.
But without all that danger of what radiation does.
Radiation and other measures, you get collateral damage.
Sure, I had radiation for prostate cancer.
The beauty of natural killer cells is they get up close and personal with the target and they specifically direct their perforating molecules on that target.
But how did you find out that That same molecule is being emitted by a viral cell, a virally infected cell, and therefore the same thing happens.
Through very careful analysis of cancer cells and virally infected cells.
Did that happen accidentally or did you look for that?
Well, this is well known in the literature.
I mean, immunologists have recognized for a long time that virally infected cells can actually express those molecules the same with cancer cells.
What we simply did was leverage that previously existing knowledge.
So you knew that going in.
That's right.
And I know for some time there have been discussions that confuse laymen like me that there may be some form in which cancer is a virus.
So, that's an interesting theory.
As far as we're concerned, it doesn't matter.
There's a bad cell out there, and we want to go after it, right?
I don't care if it's the Green Army or the Blue Army or the Red Army I have to defeat.
Fortunately, our sentry, these natural killer cells, defeat those cells.
So have you done any testing now of any kind with regard to attacking these viral cells with the killer cells?
Tell me what you've done.
Although this specific coronavirus There are no animal models that you can test or what we call in vitro models.
They're not available yet.
What we did is we went out and we looked at other virally infected cells.
Cells that are infected with viruses that are more common and we actually saw clear evidence that our natural killer cells... Coronaviruses?
Other viruses.
I know there's several other coronaviruses.
That's right.
But the category of virus is one that is clearly identifiable by these natural killer cells and can be attacked.
So in our laboratory, we showed that our natural killer cells will attack and kill virally infected cells.
That's number one.
Number two, there's some really compelling evidence from previous experience with coronavirus.
Let me just tell you about this.
After the SARS outbreak 15-20 years ago, which was also caused by a coronavirus.
Correct.
And MIR.
And MIR is also a coronavirus.
That's right.
And the Middle East version, also by a coronavirus.
The studies done after those outbreaks actually showed the patients who did worse were patients who had an underlying problem with their quality or quantity of their natural killer cells.
So that's an observation that's been published.
Okay?
So think about that.
Just a few days ago, published out of another research group, there's now evidence that the response to COVID-19, this specific virus, is associated with a defect in natural killer cells.
So this is already being observed and described, suggesting that a very logical strategy is to simply boost a patient's immune capability by giving them supplemental natural killer cells.
So now you are asking for permission from the FDA to do that phase one trial.
That's right.
That you've already done on cancer.
That's right.
And we call that an... IND.
An Investigational New Drug Application.
And generally how long does it take to have that approved?
In a normal circumstance?
The FDA, by charter, responds to those applications within 30 days.
Do they?
That's called the PDUFA date.
Yes, they do.
Generally, the FDA will have questions and they'll have comments about the application.
I mean, the general reputation of the FDA, and I don't mean to be critical at a time like this, you shouldn't, but that it's very slow.
I have to also give my own background here.
I've represented pharmaceutical companies In very, very difficult situations.
And it was my observation that they just took forever in situations where, and I'm a very impatient person, people are dying.
Come on, let's go.
Let's move.
I know we want to be safe, but...
This person, you know, doesn't have too many choices.
So, I kind of share a very similar view in the sense that this is a very unusual situation.
This is not the traditional environment where you're developing a product.
Very unusual.
Maybe the most unusual ever.
This is an emergency situation.
Absolutely.
I mean, we hear predictions it could affect the whole world.
We've got 85-year-old people that are a day away from death.
So the fact is the FDA is working tirelessly.
I know they are.
There's got to be a certain balance here about, under normal circumstances, how much risk do you take?
Critical circumstances of the worst world pandemic ever.
You just got to take more risk.
Listen, you know, regulatory systems in general are designed for the everyday environment.
Under an emergency situation, the regulatory system has to adapt and accommodate those changes.
So how long has this application been pending?
Just about two weeks.
We're expecting to hear from them any day and we're very optimistic about that.
And once they say yes?
We're going to start treating patients.
So what do you do?
You put together a cohort?
We already have the treatment sites identified.
We already have the product ready to be delivered.
You've got the patients?
And the patients are already in these hospitals.
So our...
Of course they want the treatment because why not?
I mean, if it was me or my relative, come on, let's go!
I mean, you know, we're fortunate.
You know, we have a president.
I just have to tell you, I have a history with a close, close personal friend who was told he was going to be dead from lung cancer in four months.
And he said to me, just find me, go find one of those experimental programs.
I want to just take a shot.
I've been a gambler all my life.
Get me 10%, even five.
I did.
Went down to Houston and MD Anderson.
He lived for four and a half more years.
Went to Europe, married the woman he loved.
And that's the beauty of being in a country like this, where you have some of the most brilliant minds developing experimental... And we have doctors who can evaluate and tell me, as an intelligent human being, what's my risk.
Exactly.
Once you get started, you then pick a group.
How big a group would you need for this?
In our trial design, we're looking to treat 50 to 100 patients to begin with, demonstrate the safety and the activity of the product.
But do certain people have to not be given the drug so you can compare it to them?
We're not going to be able to treat everybody, so the control group, if you will, the untreated population is out there probably in beds next to the patients who are going to get treated.
That seems so unfair.
Well, I mean, arguably, any type of development, you've got to sort of select and exclude.
That being said, I'm pretty confident that the safety of this product is going to be more than acceptable and that we're going to see that we actually boost the immune response to the virus.
So now you do that test.
Lock in on a number.
How many patients would you logically do the test on?
50 to 100.
Let's get, let's, 50?
So, but here's the thing.
How many, how many will you give the medicine to?
Start off with 50.
Okay, start off with 50, and then we, and you compare them to another 50 that aren't getting the medicine.
And we're looking at the natural history of the disease to look at whether or not they convert from infected and minimum symptoms to, for example, ventilator-dependent or not.
But here's the really neat thing.
In your cohort, we call it cohort, don't we?
In your cohort, the cohort getting tested, and the cohort that's what you call the control group.
And then to be a good result, what's the percentage differences that usually have to take place?
Again, in a rigorously controlled trial, you want to show that you have a less than 5% probability of the data being the same.
That's kind of what the statistical threshold is.
So make that a little easier for me.
So what you want is you want you want results you want results that less than one in 20 would have
would have had had they not had the treatment. Okay.
Less than 1 in 20 would have had at least 20%.
You want to show that at least 5%.
That's all.
So that's the statistical threshold.
You want to show that at least 5%.
You want to show that at least...
That's all.
So that's the sort of statistical threshold.
In the case of this particular study, first and foremost, showing that the patients tolerate
this well, that's essential.
Then demonstrating that we can lower the viral burden in patients, that by itself is a meaningful endpoint.
Showing that we can reduce the number of patients who go on ventilators, that's a meaningful endpoint.
Showing that patients who go on ventilators can get off ventilators, that's a meaningful endpoint.
All of those things will be analyzed.
If it shows that it's not dangerous, then it becomes a little bit more of a no-brainer.
That's right.
Meaning, we may be wasting time, but we're not endangering anybody if we continue with this.
So that is very important.
And clinically, it's intuitively logical that anything you can do to enhance a patient's immune system is going to be valuable in viral illness.
Now, how do you know that the cohort that's getting the medicine isn't less sick than the cohort that isn't.
By having very strict criteria for entry.
So you're careful, as best you can.
That's right.
And when you said 50 to 100, would you quickly move on to another 50?
I would say that if we see the kind of results we're hoping for, which is well tolerated,
no safety concerns, and patients are showing any improvement in any of these parameters,
we're going to work with the FDA to increase the total number of people who get access
to it.
So now, give me a sense of normally how long this takes, and if we do miracles, which used
to be my phrase in city government when I wanted things done, I tell my people, we do
miracles on 9-11.
We got to do miracles.
If it was Giuliani time, we'd be looking for results in 30 to 60 days that we could talk
about.
Okay?
Uh, responsibly do that in 30 to 60 days.
Again, I'm very, very encouraged that the level of interest and excitement among the clinicians taking care of these patients is so high.
Your guys?
All the doctors out there.
How about the FDA?
No, no, no.
I'm talking about the doctors in the field.
The FDA is going to respond to doctors in the field.
You work with the FDA.
Does the FDA realize we don't have time?
Yes.
But I think that the sense of urgency is always tempered by the FDA's sort of general tendency towards safety.
We don't want to kill anybody.
Exactly.
But again, the way I look at this, this is battlefield medicine, right?
What you want to do is you want to make sure that we have these clinical options.
And by the way, the nice thing about cellular therapy is it can work in conjunction with other therapies.
I only have about two minutes left, so the other therapies, the only other therapy that I hear talked about quite a bit is the hydroxyquinolone with Z-Pak.
Right.
And you could be doing that.
Which is very interesting.
By the way, think about this for a second, okay?
What does the malaria drug and the antibiotic do?
The malaria drug probably has very potent anti-inflammatory properties.
Of course.
Immunomodulatory properties.
And then the antibiotic is protecting against infectious agents.
And in all likelihood, the reason a Z-Pak works is it's helping to eliminate the bacterial
super-infections that come on top of a viral pneumonia.
Now, what does a natural killer cell do?
It has both immunomodulatory properties, helping to control inflammation, and direct anti-inflammation.
So what you're saying is that, although totally different agents, the process is very, very similar.
Mechanistically, we're all going after the same thing.
Stop the inflammation, which causes the adult respiratory distress syndrome, and control the infectious process that is what ultimately causes demise.
Could I ask you, doctor, if I am totally off base, and if I am, I'll stop using this analogy.
But, and I think I'm going to build a little model like this.
Isn't this like a child's war game?
So I have all these red soldiers, and there are all these white soldiers.
And the red soldiers are going to attack the white soldiers.
The white soldiers is my immune system.
Right.
When I'm young, my white soldiers are very healthy.
Right.
And they can fight.
And they can beat off the red soldiers one-on-one.
But as I get older, just naturally, even if I'm not sick, some of those white soldiers get weaker.
So when the red soldiers attack, I'm at more risk than a young person.
That's right.
But then if I have illnesses, on top of it, more of my white soldiers are lost.
So what you're trying to do is rejuvenate my white soldiers.
We're trying to put them back on the field.
We're coming in with reinforcements, okay?
Yeah.
It's a new regiment of reinforcements.
Are you going to give me new cells?
Yes.
Or are you going to make my old cells healthy?
New cells.
You're going to get new reinforcement cells.
So I'm going to get new soldiers that are going to come in and put them back on the board.
That's right.
So I want to just give you this one analogy because people talk about it, okay?
The flattening of the curve, which has been used as an epidemiologic exercise to reduce... I think we get that now.
We sort of get that.
We want to reduce the burden on the healthcare system.
Our immunologic approach, by giving natural killer cells, is to flatten the viral curve.
We want to keep the level of virus down so that your own immune system can do the job and clean it up.
Well, Doctor, this has been an extremely helpful Analysis is much too short.
You have to promise me you're going to come back.
We want to keep on top of this step by step because I'll use whatever my yelling and screaming can do to do it faster to help you.
Thank you so much for dedicating your time to this.
You couldn't be doing anything more important right now at this time.
And if there's any way that I can help you, you just call me.
I like to get called at four in the morning.
I know, Mary.
Thank you very much for having me.
Dr. Harari, God bless you for what you're doing.
I'm going to pray that this is successful.
Thank you.
You'll be back, right?
Absolutely.
All right.
Thank you.
That was a very enlightening interview.
One of the best.
And I admire the doctor because he is describing some of the most complex things you could possibly describe in ways that, you know, I can understand and you can understand.
And I think this should give you hope, shouldn't it?
I mean, you see a man like this with this tremendous background, a brain surgeon, And he's devoting himself to trying to find a cure.
And he's not just, you know, this is all very scientifically based.
We got a lot of people like this doing this.
They're going to come through.
I mean, this is the greatest country on earth.
We've produced most of the great medicines and most of the great breakthroughs.
We're going to get this done.
And we got a president, thank God, who knows how to cut the red tape!
Being engaged by this virus, which is almost like a little army.
You've heard my—a big army!
You've heard my comparisons to that.
And our army is made up of some of the best, most intelligent, most disciplined people in the history of the world.
And they're going to win.
We're going to win.
And we're going to come out of it much stronger than we ever were.
We've got to go through this little period now.
We've got to show our discipline, we've got to show our courage and strength, but we'll be rewarded for it by the grace of God.
Thank you very much, and we will be back, you know, pretty soon, to be talking about this in great length so you can understand it and you can get through it.
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