Phase 1 trials of the Neo-Kidney Augment, a novel, personalized treatment designed to enhance or replace kidney function in patients nearing renal failure, are under way in Sweden and the United States. Developed by regenerative medicine company Tengion, the Neo-Kidney Augment uses tubular epithelial cells taken from a biopsy of a patient’s diseased kidney. Over the course of four weeks, the cells are isolated and cultured, selected and treated with biomaterials, resulting in a regenerative formulation that can be implanted in the patient. Early preclinical models have shown that regenerative cells isolated from diseased kidney tissue can provide increased functional kidney mass and significant improvement in overall kidney function.
The trial will evaluate the safety of the Neo-Kidney Augment, assess early signals of its efficacy, and optimize its surgical implantation procedures. Patients will be followed for a period of two years after implantation. If the trials are successful, the treatment could significantly delay or prevent the need for dialysis in patients with advanced chronic kidney disease and give them time while they wait on the kidney transplant list or seek a living kidney donor.
Tengion and UKRO board member Dr. Manfred Mosk
Tengion filed for bankruptcy at the end of December 2014. The company, including all assets and research samples, is set to be sold to RegenMedTX LLC, where it is hoped regenerative kidney research will continue.