MADISON, Wis. – A first-of-its-kind clinical trial at the Program for Advanced Cell Therapy will examine a new method to manage kidney rejection following transplant.
The Program for Advanced Cell Therapy, or PACT, a collaboration between UW Health and the University of Wisconsin School of Medicine and Public Health, will test the use of a patient’s own mesenchymal stromal cells. In this approach, cells taken from the patient’s lip are used to treat a specific type of organ rejection called T-cell mediated rejection, also called acute cellular rejection.
An organ recipient’s T-cells react to antigens produced by the body that distinguish between native and transplanted tissue. This reaction can affect various parts of the kidney including capillaries and arteries and can cause rejection of the kidney.
Even when following current best practices for clinical management, kidney rejection occurs in approximately 10% of patients within one year, contributing to risk of long-term transplanted kidney dysfunction.
The standard of practice is to use anti-rejection drugs that suppress the immune system’s response to the new organ, according to Dr. Sandesh Parajuli, associate professor of medicine, UW School of Medicine and Public Health, and the principal investigator of the clinical trial. Parajuli also practices transplant nephrology at UW Health.
“These drugs are effective, but they have serious possible side effects like increased risk for cancer, infections and high blood pressure, among others,” he said. “We are excited to examine this therapy to see if it offers a better option that has very few to no side effects.”
In February, the Food and Drug Administration approved an investigational new drug application to allow PACT to initiate the clinical trial, which will enroll 18 UW Health kidney transplant patients with signs of T-cell mediated kidney rejection. The trial is expected to get under way in 2027.
Once the stem cells are collected from the patient, they are processed and multiplied at the PACT cell manufacturing facility at University Hospital. The cells will then be injected once under the skin of the patient’s abdomen in an outpatient procedure, and the patient will be monitored for signs of any adverse reactions.
“This type of cell therapy has shown promise in other human applications, and with the promise shown in the laboratory we are hopeful it can one day bring a better treatment to prevent and treat kidney rejection,” she said.
