Thank You Seel!
From the website:
Neo-Urinary Conduit: already in phase 1, seven patients completed. 3 more to go. They opened further sites at Sloan kettering, Baylor and University of Michigan. Now the active clinical test centers is 5.
What are findings? well, From website again:
Tengion has gained insights from the seven patients implanted to date including affirmation that the surgical procedure for a NUC implantation does activate urinary tissue regeneration in patients with bladder cancer, and a better understanding of the initial post-operative care required to maintain the patency and durability of the regenerated urinary tissue. Information already gained from this trial is being analyzed and will further support ongoing plans for a potential Phase 2/3 clinical trial.
Neo-Kidney Augment Program Update
In April 2013, Tengion announced the acceptance of the Company's Clinical Trial Application (CTA) filed with the Medical Products Agency in Sweden to initiate a Phase 1 clinical trial to evaluate the safety and delivery of its second clinical program, the Neo-Kidney Augment, in patients with Chronic Kidney Disease (CKD). The Neo-Kidney Augment is being developed with the goal of using a patient's own kidney cells to augment or replace renal function for patients with CKD who are rapidly progressing toward end stage renal disease (ESRD), and is intended to prevent or delay the need for dialysis or kidney transplant by catalyzing the regeneration of functional kidney tissue in patients with ESRD.
The Phase 1 clinical trial in Sweden will involve delivery of an active regenerative dose of Neo-Kidney Augment in patients with CKD. Tengion plans to enroll up to five patients in 2013 and will follow each patient for up to two years. Additionally, the Company plans to submit an Investigative New Drug filing for the Neo-Kidney Augment to the U.S. Food and Drug Administration during the second quarter of 2013, paving the way to initiate the U.S. Phase 1 trial in the fourth quarter of 2013 and provide initial human proof-of-concept data in 2014.
This will be HUGE!!!!!!!!!!!!
Please check your PM that I sent recently from he other site.
GLTA
