Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Patients who have been implanted with the Neo-Urinary Conduit

Implantation with the autologous Neo-Urinary Conduit

Neo-Urinary Conduit

Gary Steinberg, MD

Trinity J Bivalacqua, M.D., Ph.D.

The purpose of this study is to see if the Neo-Urinary Conduit(NUC), which is made in the laboratory from a combination of a patient's own cells and other materials can be used to form a conduit to safety allow urine flow from the kidneys to outside the body after radical cystectomy in patients with bladder cancer.

The NUC under investigation is a regenerative medicine product comprised of the patient's own smooth muscle cells, procured from a fat biopsy. Tengion has developed appropriate culture conditions to reproducibly generate the necessary quantities of SMC in vitro from autologous adipose tissue biopsies. The NUC is produced at Tengion's Good Manufacturing Practices (GMP) qualified clinical production facility. In this process, smooth muscle cells (SMC) obtained from an adipose tissue biopsy are propagated ex-vivo for approximately 3 - 4 weeks. At the end of this process, the SMCs are seeded onto the surface of a biodegradable PGA/PLGA mesh scaffold to form the NUC. The NUC is shipped to the investigative site for surgical implantation. Over time, the NUC should facilitate the regeneration of urinary tract tissue.

Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy

CT scan will be used to demonstrate that urine is able to flow safety through the NUC

CT scan and renal ultrasound will be used to demonstrate that urine is able to flow safely through the NUC through 60 months post implantation

procedure and/or product related AEs will be evaluated through month 60 post implantation

overall safety will be assess by evaluation of non-product/procedure related adverse events, vital signs and laboratory parameters

Evaluation of procedure and/or product related adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit	NCT01087697	Bladder Cancer	Neo-Urinary Con...	18 Years - 80 Years	Tengion
Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit	NCT01087697	Bladder Cancer	Neo-Urinary Con...	18 Years - 80 Years	Tengion

Spots Global Cancer Trial Database for incontinent urinary diversion