Clinical trial looks to free kidney transplant patients from antirejection medications
In the solid organ transplant world, organ rejection is one of the biggest challenges. To prevent rejection, these patients must remain on antirejection drugs for the rest of their lives.
"It's the Achilles' heel of solid organ transplants," says Clifford Miles, MD, Nebraska Medicine nephrologist. "Antirejection drugs protect the organ from rejection, but they also open the patient to long-term side effects like weight gain, high blood pressure and diabetes."
The Nebraska Medicine kidney transplant and blood and bone marrow stem cell transplant teams are collaborating in a phase 3 FREEDOM-1 clinical trial. The FREEDOM-1 study is researching how to potentially free kidney transplant patients from the lifelong burden of antirejection medicine. The trial aims to learn more about how to overcome this obstacle by transplanting a living kidney donor's stem cells into the recipient shortly after the kidney is transplanted. If you plan to receive a kidney transplant from a living donor, you and your living donor may be eligible to participate.
"We were picked to participate in this trial that involves about 15 elite medical centers across the country," says Dr. Miles. "We're ideal for this trial because we have very strong programs in both of these areas."
The outcome for living kidney transplants is very good, notes Dr. Miles. "But this has the potential to make these types of transplants even more successful," he says. "A kidney from a living donor has an average life of 15 to 20 years compared to 10 to 12 years for a deceased-donor kidney. Some transplant recipients will need three or even four transplants in their lifetime. Our hope is to find ways to make these kidneys last their entire lifetime with little or no complications."
If the research study is successful, it will also free up more kidneys for others. "One in five kidney transplant candidates on the list are waiting for a second or third kidney," says Dr. Miles. More than 93,000 people are on the kidney transplant waiting list.
One of the major risks of this trial is the potential for graft-versus-host disease. Graft-versus-host disease is a condition in which the donated bone marrow or peripheral blood stem cells recognize the recipient's body as foreign and attack the body.
This is a complication that the blood and bone marrow stem cell transplant team must manage regularly with cancer patients undergoing transplants.
To try to minimize this complication in this trial, the donor's stem cells are sent to a lab. At the lab, the cells undergo cell manipulation to remove the part of the cells responsible for initiating this rejection, says Zaid Al-Kadhimi, MD, Nebraska Medicine hematologist. "Our team will then be able to use our experience and expertise in this area to monitor and manage this potential issue."
"The results for this trial could be life-changing for these patients," says Dr. Al-Kadhimi. "It's the potential for a better quality of life and never needing a transplant again."
"We are very excited to be participating in this trial, which offers so much hope for many living donor kidney transplant patients. It's an opportunity for both fields to work together to advance kidney transplantation and apply this knowledge to other types of organ transplants in the future."
Learn more about this clinical trial
