UHealth to Serve as Site for Chronic Kidney Disease Clinical Trial
A first-in-human clinical trial targeting diabetic nephropathy and other forms of chronic kidney disease is enrolling patients in Miami.
Chronic kidney disease is a significant a global health challenge. The disease affects one in three adults with diabetes and 38% of people older than 65, impacting more than 110 million people in the U.S. and Europe.
Current treatments can delay progression but thus far no cure has been found. As chronic kidney disease advances, dialysis and transplantation are needed.
UHealth—the University of Miami Health System is looking to change that.
UHealth is serving as host site for AION Healthspan’s first-in-human clinical trial, investigating REJUVXL™ to target diabetic nephropathy and other forms of chronic kidney disease.
“At a time where the compound annual growth rate for kidney diseases has reached the rate of cancer, REJUVXL™ is uniquely positioned towards a successful clinical development,” says Alessia Fornoni, M.D., Ph.D., professor in the Katz Family Division of Nephrology and Hypertension and assistant dean for research training and development at the University of Miami Miller School of Medicine. Dr. Fornoni is a member of the scientific advisory board of AION.
Dr. Fornoni has made seminal contributions to the understanding of kidney disease. Through her pioneering work on insulin signaling, cholesterol metabolism and sphingolipid-related pathways, Dr. Fornoni uncovered novel pathogenetic mechanisms and therapeutic approaches for glomerular disorders.
Clinical Trial Overview
The study aims to assess the safety, tolerability and early-efficacy signals of REJUVXL™ in patients with chronic kidney disease.
The clinical trial will determine if the therapy inhibits, halts or even reverses chronic kidney disease progression, potentially preventing end-stage renal disease dialysis and kidney transplantation. The U.S. Food and Drug Administration (FDA) has authorized the investigational new drug (IND) application to proceed for the Phase 1/2 clinical trial.
“As the principal investigators on the chronic kidney disease trial, we are excited to learn about the potential of REJUVXL, which aims to transform the landscape of chronic kidney disease treatment,” said Yelena Drexler, M.D., assistant professor in the Katz Family Division of Nephrology and Hypertension. “The objective is to target the underlying causes of chronic kidney disease—chronic inflammation and fibrosis—while promoting tissue repair and regeneration. If successful, this therapy has the potential to change the course of the disease for millions of patients, reducing the need for dialysis and transplant, and ultimately improving patient outcomes and quality of life.”
About REJUVXL Cell Therapy
REJUVXL is a cell therapy derived from perinatal tissues that are usually discarded after delivery of healthy newborn babies. Cell doses can be administered through intravascular infusion (like a blood transfusion) and do not require anti-rejection drugs for the recipients. These cell products represent the youngest source of cells that can be obtained after birth, eliminating the need for embryonic or fetal cell products and their associated risks.
Possible mechanisms of action include:
• Reduction of inflammation and fibrosis
• Modulation of the immune system
• Promotion of angiogenesis and tissue regeneration
Optimized for chronic inflammatory and degenerative diseases, REJUVXL is first being evaluated for chronic kidney disease, with potential expansion into additional indications.
Tags: chronic kidney disease, clinical trials, Dr. Alessia Fornoni, Dr. Yelena Drexler, Katz Family Division of Nephrology and Hypertension, kidney disease