EXCLUSIVE: A founding partner of Kleinberg Lange Cuddy & Carlo and a fixture in the Hollywood legal community for five decades, Kenneth Kleinberg built his practice lawyering the likes of Jack Nicholson, J.K. Rowling, Johnny Depp, musicians like Toby Keith and brands like Lego, among many others.
If you ask the attorney what his ultimate crowning life achievement might be, he hopes it will be the fruition of co-founding the University Kidney Research Organization. A byproduct of Kleinberg’s own medical woes that ended in a kidney transplant, UKRO has been a catalyst for stem cell-based research that has led to the development of a synthetic kidney its makers believe will not only be ready for transplants inside of a decade, but will also eliminate the body’s natural inclination to reject any replacement organ harvested from another human because it is generated with stem cells from the recipient.
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“What has already been achieved is extraordinary and when it’s fully perfected, the idea of using stem cells to replicate other organs in the human body opens a whole new area of science and medicine,” Kleinberg told Deadline. “If this is successful and the kidney perfected, it’ll be one of the biggest medical breakthroughs ever, on par with the Salk vaccine for polio.”
Kleinberg believes it will be the most significant recent medical breakthrough since AIDS was turned from a death sentence to a treatable disease.
In a moment where everyone from Hollywood labor unions to its developers are warning of the dangers of AI, the potential results here are staggering. Zhongwei Li, a PH.D and lead researcher on the Synthetic Kidney Project in the USC/UKRO Disney Research Center, has led the charge to build a synthetic kidney. It is now being tested on mice. It has worked well enough, said Li, to fuel optimism that human clinical trials are a few years away, and, contingent on funding, they are within a decade of being able to generate synthetic kidneys for transplant into humans. That would be a revolutionary feat of tissue engineering, a breakthrough that would have a distinct advantage over life-saving transplants.
Kleinberg now hopes Hollywood heavyweights will answer the call and help raise the funds needed to see through a medical miracle.
How did an attorney whose domain is creations like Hogwarts, Lego Batman and Jack Sparrow become a key player in such a medical breakthrough?
Kleinberg’s kidney odyssey goes back to early 1990 when his life changed during a business trip to Mipcom in Cannes.
“I woke up one morning, and my body was uncomfortable and seemed very puffy,” Kleinberg recalled. “The next day it was worse. By the time I was ready to leave after three or four days, I was like one of those toys the children get where they pump up a plastic figure with air. I was like the Stay Puft Marshmallow Man from Ghostbusters.”
Kleinberg had never experienced anything like this. By the time he got home, he was told that he had the equivalent of 30 extra pounds worth of fluid rattling around in his body and he was sent right to the hospital.
“The swelling was water retention,” he said. “You kind of hear fluids sloshing around literally in your body, because water will be retained in your chest cavity and in your lungs and worst of all, in your heart. My doctor sent me to a kidney specialist. I didn’t know anything about nephrology at all, but they immediately diagnosed it as a kidney malfunction. I ended up seeing a nephrologist at USC, who turned out to be the head of the Department of Nephrology there. He said, ‘I don’t care if you go back to Cedars Sinai, or wherever else you might have sought treatment, but you have to be in the hospital right now. I checked into the Keck Hospital at USC. They put me on a regimen of a drug called Lasix and, and other drugs to essentially contain the swelling, because by the time I arrived there to be treated at USC, I was filled with water, 30 pounds of it. My calves and my lower legs were almost the size of my thigh.”
Had he let the crisis linger, it might have been fatal.
“You would eventually expire,” he said. “The thing is, the kidneys not only filter excess fluid out of the body, but they filter toxins. If you have non-functioning kidneys, that’s called end-stage renal failure where you have all of these toxins accumulating in your body. You start to get a yellow appearance, you get terribly sick, horribly nauseous and it’s the beginning of the end of your life because the kidneys control everything. They affect your heart, they control your liver, everything is impacted. So if you get kidney failure, you’re in big time trouble. And so they put me on this regimen to get rid of the fluid and to see why the kidneys were malfunctioning.”
The diagnosis: minimal change disease, a kidney malady that while not life threatening kept Kleinberg in the hospital for six weeks, before his kidneys began working again. He did his legal work from his bedside, and had time to begin asking questions of the experts treating him at USC. One of them was Vito Campese, his nephrologist, with whom Kleinberg would eventually form UKRO.
Said Kleinberg: “I constantly asked them, what causes this? And they would say, ‘We don’t know; the kidney is one of the least understood organs.’ And so the expertise in treating it as, as my physician said to me, it’s a little like throwing darts at a dartboard in terms of what medical could give you an answer that is an understandable and not in scientific terms or medical terms, just common man’s language.”
Kleinberg didn’t need dialysis then, and while the perception of “minimal change disease” sounds not that bad, it is the gateway to worse. “They were able to arrest the progression of the malady and I was not on dialysis, but that would be where I would be headed if it continued,” Kleinberg. “This was 1990, and I thought, we are on the edge of the millennium, and medicine doesn’t know anything about this disease, what causes it, and treatment is a guessing game?”
Six months after restarting his life and getting tested daily, “I started to see this indicator in my urine and in my blood again,” he said. “And that was a warning sign that trouble was around the bend. I ended up starting to really feel awful and I looked, well, the way I look now, and I was back into the hospital with a more virulent form of kidney disease into which this first one had expanded.”
This time, dialysis was unavoidable, because his kidneys were not filtering the toxins in his body.
“I was in the hospital a straight 13 weeks, which was really a challenge,” he said. “I was pretty sick for a while. And during that time they started to give me some dialysis because it was needed to kind of get the edge on the disease (he was diagnosed with focal segmental glomerular sclerosis, known as FSGS). But they could not say what caused this, even though it was a more common form of kidney disease than the first one. The treatments become something of a guessing game. At the end of that period of hospitalization, they gave me a warning that I was probably on the edge of complete end-stage renal failure, and I would need to prepare for that. But all during that period of time, what kept going through my mind is how incredible it is that we live in a sophisticated city, in the wealthiest country. There is a lot of wealth here in in the medical field. Why wasn’t there more research in kidney disease?”
After six years of dialysis treatments – each took several hours and only brought his kidneys to operate at 15% capacity – his organs were failing. He needed a new kidney. He could get on a long line, or…
“There are those who’ve found other paths to the solution,” he said. “For example, they will go abroad and try to buy an organ. When I was first diagnosed and word got out that I was a kidney patient, I had any number of people, particularly European friends, who said, ‘What are you crazy? Why don’t you let me get you a kidney?’ I said, how are you gonna get me a kidney? ‘Well, I have connections in certain places, and there are countries where you can buy a kidney,’ I was told. You can go to India and buy a kidney. You can go to many places that have a substantial number of poor people who are struggling, and there are people who will sell you a kidney.”
The whole notion of failing health, of long dialysis and waiting for an organ that’s a match is stressful because you are on call and can find that the donor had cancer. Humor columnist Art Buchwald once had the determination to chase Paramount through the courts to expose studio financial accounting with his lawsuit on Coming to America, but he finally tired of his failing kidneys. “He gave up,” Kleinberg said, adding that Buchwald checked into hospice, refused dialysis, and died. Kleinberg was more fortunate. An organ donor killed in a motorcycle crash was a match for him, a transplant procedure was successful, and Kleinberg was whole again.
Rather than breathe a sigh of relieve and move on, Kleinberg bounded out of bed determined to help right what he considered an unseemly situation, particularly for a massive portion of a global population not in his financial position and who could barely afford these treatments.
“I’d say to Dr. Campese at the Keck Hospital at USC that somebody somewhere must be investigating this,” Kleinberg said. “How can a disease that affects so many people not be the subject of intense research? He said, ‘Well, it isn’t. We have some research in this country and elsewhere in regard to kidney disease. But the difficult thing to handle the kidney is, it’s the most complex organ in the body, on the same level as the brain. The kidney has a great multiplicity of different cells that do various functions. The reason we have difficulty researching, the kidney is made up of millions of…think of them as like a finger and a cell. And each one is a group of cells bound together, let’s say three different cells that all do different things simultaneously, which is why the kidney is so hard to treat.’ ”
So, Kleinberg and Campese formed UKRO in 2002, to raise money to find causes and improve treatment of kidney diseases. They eventually aligned with Keck and USC, which already had a stem cell institute established by philanthropists Edythe and Eli Broad. Andrew McMahon is the director of the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at USC. Widely regarded as the best stem cell scientist in the world, McMahon recruited Li from the Salk Institute for Biological Studies in La Jolla, where he undertook his postdoctoral training before joining USC in the fall of 2017. UKRO was part of that, said McMahon, and their collective efforts have made the breakthrough possible.
“The world was already excited about stem cells and how they can generate complex organ cell types,” McMahon told Deadline. “But there are other types of cells that you’ve heard much less about are called progenitor cells, which have a role in generating parts of the kidney system. Dr. Li has pioneered strategies to … perfect the individual parts of what you might think of as a complex machine. If you could perfect the parts to make a smoothly running functional machine, that machine is likely to work much better. In this case, the machine we’re making is incredibly complex. It’s the main filtration system of our body, the kidney. There are good indications that the synthetic structures that Dr. Li is generating have the ability to generate urine, in the animal models. The next step is to improve on that by incorporating more cell types into those developing structures and to engineer those kidney-like structures so they can for example, be connected properly so that when the urine is produced, it can be exited from the body at that moment. This requires some additional approaches to the strategies he’s using.”
I ask McMahon, was there a particular eureka moment to get to this point?
“Less of a eureka moment than the coming together of unique complimentary expertise,” he said. “The eureka moment was thinking together, that we have all we need amongst our groups to be able to take this forward in a meaningful therapeutic way. We’ve got teams of people, Dr. Li who has led this really innovative approach to develop progenitor cells and make and perfect individual kidney issue types. We’ve got people who are experts in the engineering of these issues into synthetic structures that would be better suited for the needs of the synthetic kidney function. It was collecting all these different components together, which we’ve managed to do. And that is what makes us all look at each other and say, this can really work.”
Kleinberg now hopes that Hollywood leaders can help on this next leg of the race. Charities battle for donations, and here, the more money raised, the faster they can perfect the synthetic kidney. UKRO has raised north of $2 million over its tenure, in what has largely been grassroots funding efforts. Kleinberg is in the formative stages of knocking on doors to create a board of Hollywood philanthropists to speed the process and eradicate a disease that just claimed the life of Tina Turner.
“There are other groups in the United States that are trying to do the same thing in different ways, and unfortunately for a medical problem that’s as big as this one, it’s shocking that we don’t have more funding for research in kidney disease,” he said. “Some of this will depend on venture capital pharmacy from the private sector, when we perfect the synthetic kidney and companies will want to be part of owning the medical patents. That’s how these breakthroughs have been accomplished for the most part. That’s necessary because you can’t totally depend upon the NIH and public funding, which can vary depending on the administration and what people are supporting.
“On a scale, we’ve gone from two to 10 since this started and what was happening before, but we need to go from 10 to 20, and that requires funding,” he said. “There are a lot of people who’ve been involved in this effort, and all of them have given us their time and some of their money and stuck with us even in challenging years. Part of the lesson I’ve learned here is perseverance.”
Click here for more information and to donate to UKRO.
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