Clinical Trials

TNG-CL009 A Phase 1 Open Label Exploratory Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy

Study Population

Inclusion Criteria:
1. Male and female subjects 18 to 80 years of age
2. Patients undergoing radical cystectomy for treatment of bladder cancer clinically staged as no greater than T2, N0
3. Indicated and agreed between physician investigator and patient to have an incontinent conduit as the diversion mechanism of choice post cystectomy
4. Willing and able to sign informed consent

Study Population
Exclusion Criteria:
1. History of cancer (other than bladder cancer, non metastatic prostate cancer, or non melanoma skin cancer ) within the past 5 years
2. Evidence of cancer metastasis following staging procedures including:
    a. CT of the chest, abdomen, and pelvis
    b. Pelvic exam under anesthesia

3. Life expectancy of less than 2 years
4. BMI > 33
5. History of pelvic radiation therapy
6. Non pelvic radiation therapy within the past 5 years
7. Patients who have received chemotherapy in the past 5 years with the
exception of treatment with neoadjuvant chemotherapy for the current bladder tumor if completed prior to enrollment
8. Expected need for chemotherapy within the 3 months immediately post implantation of the NUC
9. Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin
10. Known hepatitis, HIV, or TB
11. Immunocompromised subjects or subjects receivingimmunosuppressive agents (inhaled corticosteroids and chronic lowdose corticosteroids (? 7.5 mg per day) are permitted). Brief pulsed corticosteroids for intermittent symptoms (e.g. asthma) are permitted
12. Subjects with a history of an anaphylactic or severe systemic reaction to the biodegradable polymers glycolic acid (PGA) and Poly-DLlactide- co-glycolic acid (PLGA)
13. Subjects with uncontrolled diabetes (defined as metabolically unstable and / or HbA1c > 7.5%)
14. Subjects with incapacitating cardiac and/or pulmonary disorders (defined as ASA score ? 3)
15. History of alcohol and/or drug abuse
16. Subjects with renal insufficiency defined as eGFR< 50mL/min/1.73m2
17. Subjects with a serum albumin value < 2.5 g/dL or clinically significant hepatic disease
18. Subjects with acute or chronic abdominal skin infections
19.Subjects with acute or chronic inflammatory bowel disease
20. Subjects with bleeding disorders and /or with low platelets requiring active treatment
21. Female subjects who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of child bearing potential and not using a highly effective method of birth control (including sexual abstinence). A highly effective method of birth control is defined as one that results in a low failure rate (i.e.less than 1 percent per year) when used consistently and correctly,such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner. Subjects must be willing to continue birth control methods throughout the course of the study.
22. Any circumstance in which the investigator deems participation in the study is not in the subjectâs best interest
23. Unwillingness, inability, or unlikely compliance with study related procedures
24. Use of any investigational product within the previous 3 months
25. Prior participation in the study

The purpose of this clinical trial 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 standard surgical materials, can be used to form a conduit (tube) to safely allow urine flow from the kidneys to outside the body after removal of the bladder in patients with bladder cancer. The NUC is designed to eliminate the need to use a patient's own bowel tissue in reconstruction of the urinary tract following cystectomy, thus potentially avoiding some complications

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

Phone: 443-287-0385