Clinical trial for lab-grown neo-bladder to help spinal cord injury patients

Urologists at Thomas Jefferson University Hospital are studying whether a neo-bladder construct grown from a patient's own cells can improve bladder function for adult spinal cord injury patients.

Jefferson is only one of six sites in the U.S. enrolling participants in this clinical trial for the lab-grown neo-bladder construct that will involve a total of 10 patients.

“It's never been done in adults before,” said primary investigator Patrick Shenot, M.D., instructor in Urology, Jefferson Medical College of Thomas Jefferson University, noting that a similar study is being conducted with children with spina bifida.

The neo-bladder constructs are being developed by Tengion, Inc. in their pilot manufacturing facility.

Each neo-bladder construct consists of a biodegradable scaffold seeded with urothelial and smooth muscle cells cultured in Tengion's facility from the patient's own bladder cells.

To participate in the study, a patient must be 18 to 65 years of age, have had a spinal cord injury for more than a year and diagnosed with a neurogenic bladder that is not adequately responding to medical therapy.

The urologist first performs a biopsy on the patient to retrieve the cells. The cells are then sent to Tengion's manufacturing facility where they are grown in culture and then seeded onto a biodegradable scaffold in the shape of a bladder.

Then, the patient returns to hospital and the urologist will implant the neo-bladder construct in a procedure known as augmentation cystoplasty or bladder augmentation.

“The neo-bladder is expected to continue to regenerate within the patient, using the body's inherent regenerative capabilities, and if successful may result in improved bladder function,” Dr. Shenot noted.

The field of regenerative medicine is anticipated to be an area of intense interest and expansion in the coming years, said Dr. Shenot.

“While this first trial in adults is for patients with bladder control problems due to spinal cord injury, the possibilities for expansion into oncology related areas are promising,” he said.

http://www.jeffersonhospital.org/