Technology developed by Anthony Atala, MD, Director, Wake Forest Institute for Regenerative Medicine, Adjunct Professor of Surgery at the University of Pittsburgh, and McGowan Institute collaborator, heads for Phase 2 clinical trial. Ten adults with neurogenic bladders due to spinal cord injuries will be enrolled in the trial to study autologous neo-bladders. Neurogenic bladder is a condition that can occur due to spinal cord injury and may lead to kidney failure and incontinence, even when patients receive optimal medical treatment.
Tengion Inc., a Pennsylvania start-up company developing regenerated human organs, will conduct the study. A small biopsy will be taken of each person’s bladder. The healthy cells are then grown on a biodegradable scaffold in a lab and then surgically implanted in the body where the bladder continues to grow.
This study is evaluating the safety and effectiveness of the neo-bladder construct at 1 year after implantation. The neo-bladder construct design is based on nearly two decades of research from Children’s Hospital Boston (a teaching affiliate of Harvard Medical School), MIT, The Wake Forest Institute for Regenerative Medicine, and Tengion. If all goes well, Tengion hopes to have the first bladders commercially available early in the next decade.