LOUISVILLE, Ky. — Robert Waddell is a kidney recipient, but he hasn’t taken immunosuppressants for 10 years. It’s because he decided to opt into a cell therapy clinical trial when polycystic kidney disease forced him into needing a transplant.

“I fought tooth and nail to get in this program. I moved from Louisville to Chicago for the actual transplant to make it happen,’ said Waddell. 

The cell therapy that was born at the University of Louisville is called FCR001 and it aims to allow kidney transplant recipients like Waddell to stay off immunosuppression drugs they would otherwise need for the rest of their lives. Due to polycystic kidney disease in his family, he’s seen first hand the side effects his loved ones had to endure.

“She takes all the drugs just like my mom and cousin did and she has the side effects. Her skin is paper-thin, she’s got complications as a result of the drug, she probably takes 20 pills a day to keep the kidney healthy in her body,” he said.

The cell therapy consists of stem cells taken from the organ donor and processed at the Talaris Therapeutics, then it is infused into the organ transplant recipient. The goal is to create a durable dual immune system. These immune systems then coexist, the body then sees the donated organ as part of the body.

In an earlier phase 2 trial, the therapy allowed 70 percent of living donor kidney recipients to be weaned off their immunosuppression treatments. Waddell was the first one weaned off and has been off the drugs for a decade with no signs of organ rejection.

“I feel like I was reborn because, with polycystic kidney disease, you don’t know how bad you feel because it is slow to degrade and by the time it degrades to when you need a kidney that becomes your normal. When you put a fresh kidney, you realize what everyone else feels and it is amazing,” he said.

He hopes that with phase 3 of the clinical trials being out there now, people will consider it and will enjoy a life free of immunosuppression drugs and organ rejection.

“Hopefully it’ll be standard of care after this stage 3 clinical trial and it’ll be an option for everyone including my son down the road if he needs it, that’s what I’m banking on,” he said.

The phase 3 trial is expected to enroll 120 adult living donor kidney transplant recipients at multiple sites across the U.S. To date, the trial has been initiated at five clinical sites around the country.