New Clinical Trial Testing New Methods for Managing Kidney Transplant Rejection

Cells taken from the patient's lip will be injected into the abdomen as a means to treat a specific type of organ rejection.
April 2, 2026

Key Highlights

  • The trial uses a patient’s own mesenchymal stromal cells derived from lip tissue to target T-cell mediated rejection.
  • Stem cells are processed, multiplied, and injected under the skin in an outpatient setting, offering a minimally invasive treatment option.
  • This approach aims to reduce the risks associated with traditional immunosuppressive drugs, such as infections and cancer.
  • The therapy has shown promise in other human applications, supporting its potential effectiveness in transplant rejection management.
  • FDA approval of the investigational new drug paves the way for further research into personalized cell therapies for organ rejection.

A new clinical trial will test the use of a “patient’s own mesenchymal stromal cells” as a means of managing kidney rejection following a transplant.

Cells taken from the patient’s lip will be used to “treat a specific type of organ rejection called T-cell mediated rejection, also called acute cellular rejection.” T-cells “react to antigens produced by the body that distinguish between native and transplanted tissue,” which can affect the kidney in such a way as to cause rejection. Kidney rejection occurs in “approximately 10% of patients within one year, contributing to risk of long-term transplanted kidney dysfunction.”

Standard practice is to use “anti-rejection drugs that suppress the immune system’s response to the new organ,” which can have “serious side effects like increased risk for cancer, infections, and high blood pressure, among others.”

The FDA recently approved an investigational new drug application to initiate this clinical trial. Stem cells will be collected from the patients and then “processed and multiplied” before being “injected once under the skin of the patient’s abdomen in an outpatient procedure.” This type of cell therapy has “shown promise in other human applications.”

About the Author

Matt MacKenzie

Associate Editor

Matt is Associate Editor for Healthcare Purchasing News.

Sign up for our eNewsletters
Get the latest news and updates