A kidney transplant that lasts for life. It’s the ultimate goal. But the drugs that keep a donor organ going also pose the greatest threat. Now a new approach to fighting off rejection – but is it safe? One woman says she’s willing to take a chance to find out.
It looks like a scene from a sci-fi movie … a bag of human cells sways steadily. Scientists prep tubes and machines in an ultra-sterile lab. But what looks like a complex experiment addresses a simple yet discouraging fact.
Dr Joseph Leventhal, Northwestern Medicine Transplant Surgeon: “If you get a kidney transplant it doesn’t last forever. With a living donor kidney transplant, the average life expectancy is maybe 15 to 20 years under the best circumstances.”
Over time donor organs fail, largely due to the side effects of the powerful medications transplant recipients must take for life – drugs that help ramp down, weaken the immune system so a patient’s own body won’t attack the foreign organ. They perform a life-sustaining function but come with a life-threatening risk.
Dr Joseph Leventhal: “They can increase your risk of certain infections, they can increase your risk of certain cancers and they are imperfect. Over time the immune system can still react against the organ, and we see something called chronic rejection.”
The ultimate goal is to reduce, perhaps one day eliminate, the need for the toxic anti-rejection drugs.
Dr Joseph Leventhal: “What we hope we can do is turn the situation where it’s one kidney for the life of the individual. You get that transplant and through better control of the immune system and through avoiding the side effects of the drugs, it will give you a kidney that will last for as long as you need it.”
Just two weeks after undergoing a kidney transplant, Lauren Novak is well versed in her new routine. It all began with blurry vision and migraines, but quickly escalated to a major health crisis.
Lauren Novak, kidney transplant patient: “Over the period of about 24 hours they said, ‘You are in end stage renal failure, you’re going to need to go on dialysis and you’re going to need a kidney transplant.’ It kinda hit me like a brick out of nowhere.”
Daily dialysis kept the 28-year-old alive while family and friends underwent testing to be her donor. The best match? A college friend eager to help.
Lauren Novak: “He was absolutely relentless about it.”
And Lauren was relentless in her research – not only searching for a transplant surgeon, she wanted to be part of a clinical trial. Her investigation led her to Northwestern Medicine’s Dr Joseph Leventhal.
Lauren Novak: “He told me the potential risks and potential benefits. I was ecstatic. It was almost an immediate go.”
She signed on to a phase 1 safety study – not only to help advance the research but with the hope she’d experience a positive effect from the new treatment.
Lauren Novak: “The thought of having to take immunosuppressants for the next 30 or 40 or 50 years even can be a huge strain on your body.”
The study starts here – blood drawn from the patient and stored before the transplant is taken to the lab. The next step … separate out the regulatory t-cells. They play a critical role in controlling the immune system. There are about 10 million in this bag – but the scientists in this lab will help the cells replicate – growing them in number – and 60 days after her transplant, Lauren will be re-infused … with one billion.
Dr Joseph Leventhal: “We’re trying to use the patient’s own immune regulatory machinery, their own regulatory cells, to do the job in a way that would hopefully eliminate entirely or significantly the need for drug based immunosuppression.”
But this is a phase 1 study – meaning its purpose is to determine if patients can safely tolerate the experimental treatment.
Dr Joseph Leventhal: “The major safety issue is making sure these cells don’t become effector cells and cause a rejection episode, or that the cells would inappropriately suppress the immune system of the transplant recipient.”
Still, Lauren is excited about the possibility of one day reducing her dose of immunosuppressants.
Lauren Novak: “The less of that I have to take the better it’s going to be for me long term for my overall health.”
Dr Leventhal says the regulatory cell infusion has the potential to be used in any patient who receives an organ transplant … as well as patients with auto immune disorders like rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. To learn more about the study, call (312) 695-1703