About one in seven people in the United States suffers from chronic kidney disease (CKD), with diabetic kidney disease (DKD) being the main cause.
With CKD, the kidneys are damaged and cannot filter blood as well as they should. Because of this, excess fluid and waste from blood remain in the body and may cause additional health problems — including high blood pressure, heart disease, stroke and early death.
Existing therapies like dialysis may delay the decline of kidney function, yet many patients continue to progress to kidney failure.
But now there's a potential new treatment being evaluated for patients with CKD. It relies on cell therapy — which refers to the transfer of a specific cell type, or types, into a person to treat or prevent a disease. UC Davis Health is among hundreds of sites hosting clinical trials investigating cell therapy for CKD. The Proact study is evaluating the efficacy and safety of an investigational product called Renal Autologous Cell Therapy (REACT). This first-in-class cell therapy for CKD could potentially preserve kidney function in people whose kidneys have become damaged because of type 2 diabetes.
"Current treatment options for CKD involve uncomfortable physical side effects and a lifetime use of medications," said Prasanth Surampudi, a UC Davis Health associate professor of endocrinology, diabetes & metabolism, and principal investigator for the trial. "Additionally, these treatments just control the condition and do not cure it. Finding a therapy that could improve kidney function would tremendously improve the quality of life for patients suffering from CKD."
"This therapy administers a person's own cells that have been selected, multiplied and formulated for delivery outside the body. The technology has the potential to restore kidney function by using a patient's own SRCs to restore the natural healing processes."-Prasanth Surampudi
What is REACT?
REACT is a cell-based advanced therapy composed of selected renal cells (SRC), which are naturally involved in the process of kidney repair and regeneration. It is created from the patient's kidney tissue obtained through a biopsy.
To manufacture REACT, the renal cells taken from the patient are expanded and the SRCs are isolated and selected. SRCs are then formulated into the cryopreserved or gelatin-based hydrogel at a concentration of 100 x 106 cells/mL.
"This therapy administers a person's own cells that have been selected, multiplied and formulated for delivery outside the body," explained Surampudi. "The technology has the potential to restore kidney function by using a patient's own SRCs to restore the natural healing processes."
Proact study design
The study is a randomized, blind, placebo-controlled clinical trial — meaning neither the participants nor the researchers know who is receiving the cell therapy treatment or placebo.
Approximately 685 adults 30 to 80 years of age who have been diagnosed with CKD and type 2 diabetes without requiring kidney dialysis will participate in the worldwide study. Half of the qualified participants will undergo a biopsy and receive two injections of cells. The other group will undergo a simulated biopsy and receive two simulated injection procedures.
Participants will receive their first injection 12 weeks after their biopsy and then be monitored by researchers during five follow-up visits over a three-month period. They will then receive their second injection and be monitored during four follow-up visits over the next month.
In total, participants will be monitored by researchers over a five-year period with follow-up visits every three months after the initial monitoring timeframe.
