Eliminating the Need for Anti-Rejection Drugs for Transplant Recipients

Shannon Walker and Courtney Howard sit side by side
Shannon Walker (pictured left) donated the kidney that saved the life of her sister, Courtney Howard (pictured right), and the stem cells used to spare Courtney from a lifetime of taking anti-rejection medication. (Image: MedStar Health)

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(January 9, 2022) — Courtney Howard, 43, needed a kidney transplant to save her life and be cured of hereditary polycystic kidney disease. While she knew the kidney transplant was inevitable, what she did not know is that her sister Shannon Walker, who had vowed to provide that kidney when it was needed, would also donate specialized cells collected from her blood that carried the potential to spare Courtney from a lifetime of taking anti-rejection medication.

Through Georgetown University Medical Center, clinical trials are underway at MedStar Georgetown Transplant Institute, where researchers are exploring if cellular therapy created from the specialized cells can modify a kidney recipient’s own immune system to prevent rejection of the donated organ, eliminating the need for the anti-rejection medications — costly drugs with the potential for serious side effects.

Living Longer With Better Quality of Life

“If we can use cellular therapy to train the recipient’s immune system to not reject the transplanted organ, we would expect patients to live longer with a much better quality of life,” said Matthew Cooper, MD, director, Kidney and Pancreas Transplant Program at MedStar Georgetown Transplant Institute and professor of surgery at Georgetown University School of Medicine. “If successful in these studies, this approach would offer new hope for kidney transplant patients.”

Currently, patients receiving a kidney transplant are required to take anti-rejection medications regardless of how closely related or matched they are to the donor. In addition to having substantial side effects, the medications oftentimes do not completely control damage to the kidney from the recipients’ immune system and can ultimately cause the kidney to fail.

Cooper, who also serves as president of the United Network for Organ Sharing (UNOS) board of directors, said that eliminating the need for anti-rejection drugs has the added benefit of sparing both the recipient and health care system the significant financial burden.

How Cellular Therapy Works

To derive the cellular therapy, specialized cells are isolated from the kidney donor and then delivered as a single dose infusion to the kidney recipient after transplant. These cells are collected in a process like that of donating platelets. This therapy could potentially restore patients’ immune tolerance by establishing a mix of immune cells in the transplant recipient — both their own cells and those collected from the donor.

Cellular transplant therapy is the focus of Georgetown University studies in various stages at MedStar Georgetown Transplant Institute aimed at establishing a future for kidney transplant patients free of a life of immunosuppressant medication.

Enrolling Transplant Patients in Two Studies

The MedStar Georgetown Transplant Institute has recently begun enrolling patients for the Freedom 1 study, which is a Phase III study for donor/recipient pairs regardless of how unmatched their immune systems are. Unlike Courtney and her sister, whose immune systems were perfectly matched, in the recently initiated Freedom 1 study, recipients do not have to be an immune match with their donor to receive the cellular therapy, allowing more donor/recipient pairs to enroll. The goal of the Freedom 1 study is to assess the potential of a one-time, investigational cell therapy, derived from the kidney donor’s cells, to enable living donor kidney transplant recipients to durably discontinue anti-rejection drugs without rejecting their donated kidney.

This phase III clinical trial assesses the safety of the therapy along with the efficacy and overall benefit of cellular therapy in the new living donor kidney transplant relative to standard-of-care immunosuppression medications. Participants must be at least 18 years old and younger than 60. They will be randomized to receive either the investigational cellular therapy or standard immunosuppressant therapy and will be followed for five years.

MedStar Georgetown Transplant Institute also expects to begin enrolling patients soon in the Freedom 2 clinical study. In the Freedom 2 trial, researchers will assess the safety, efficacy and overall benefit of the same cell therapy in people who are within a year of having had a kidney transplant. Past donors and recipients in this phase II study must be at least 18 years old and younger than 60. All participants will receive the investigational cellular therapy. They will be followed for five years. Freedom 1 and Freedom 2 are both sponsored by Talaris Therapeutics.

“This trial will give those individuals who were transplanted before the studies started the opportunity to receive this investigational therapy and potentially help shape the future for transplant recipients. There may even be the potential of extending such therapies to recipients of deceased donor organs in the future,” Cooper adds.

Life Without Anti-Rejection Medication

Courtney Howard said she was glad to participate in the clinical trial, which has successfully resulted in her not needing immunosuppressants for the rest of her life.

“It gives me hope for my health and quality of life that I won’t have to endure the complications that my mom (who had polycystic kidney disease) had to due to immunosuppressants,” said Courtney. “I get up every morning, I work out, go to work, and spend time with my family and friends just like everyone else. Now everyone has to keep up with me!”

“The greatest challenge in kidney transplantation is improving long-term outcomes for the recipients after the transplant,” said Cooper. “If we can take steps to help ensure a longer and healthier life for the newly transplanted organ, than we can positively impact the quality and length of life for our patients.”

For information about these clinical trials, including potential risks and side effects and criteria for enrollment, please contact Megan Hausler, MBA, RN, BSN, CCRP, research director, Center for Translational Transplant Medicine, MedStar Georgetown Transplant Institute, and Georgetown University Medical Center, by phone: 202-444-4898 or email Megan.P.Hausler@gunet.georgetown.edu.