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news.The Medical Products Agency (MPA) in Sweden, has approved Tengion's clinical trial application (CTA) for neo-kidney augment phase 1 trial.
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The safety and delivery of Neo-Kidney Augment product will be assessed in around five patients with advanced chronic kidney disease (CKD) in Phase 1 trial.
Tengion president and chief executive officer John Miclot said, "We will use the data from this trial to establish safety and a delivery approach for our planned U.S. Phase 1 trial, which we expect to start in the fourth quarter of 2013."
Neo-Kidney Augment is developed to catalyze the regeneration of functional kidney tissue in CKD patients thereby preventing and delaying the need for dialysis or kidney transplant.