Spots Global Cancer Trial Database for Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
Official Title: A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy
Study ID: NCT01087697
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Chicago, Chicago, Illinois, United States
The Johns Hopkins Medical Institutions, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Baylor College of Medicine, Houston, Texas, United States
Contact Details
Name: Gary Steinberg, MD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR
Name: Trinity J Bivalacqua, M.D., Ph.D.
Affiliation: The Johns Hopkins Medical Institute
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
