RECRUITING

Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures

Conditions

Urologic Diseases Male Urogenital Diseases Urethral Stricture Urethral Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase I clinical study to determine the safety and efficacy of using autologous, engineered urethral constructs for the treatment of urethral strictures in adult males. The proposed study design is a prospective non-randomized and uncontrolled single-center investigation. Autologous urothelial cells (UCs) and smooth muscle cells (SMCs), obtained from enrolled male subjects' bladder tissue samples, will be culture expanded in vitro and used to seed tubular PGA scaffolds to create autologous urethral constructs for the repair of urethral strictures.

Official Title

A Phase 1 Pilot Safety and Feasibility Study of Autologous Engineered Urethral

Quick Facts

Study Start:2025-01

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03258658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Stricture of the urethra meeting the following criteria: * Patients must be available for all follow-up visits. * Ability to speak English.	* Strictures of the meatus or prostatic urethra; any urethral stricture associated with or suspected to be urethral carcinoma, or strictures due to pelvic distraction injuries. Strictures \<10 mm or \>60 mm, as determined by urethrography, and criteria for bulbar urethral strictures excluding those with strictures \<20 mm and \>60 mm, as described by urethrography. * Presence of untreated urinary tract infection. * Presence or prior history of lichen sclerosis et atrophicus (previously termed 'balanitis xerotica obliterans'). * Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders. * Any urological condition that would be likely to require additional urethral instrumentation during the period of investigation, including, but not limited to benign prostatic hyperplasia requiring treatment, use of alpha blockers, active prostate cancer, an unevaluated elevated prostate surface antigen (PSA), bladder cancer, or any recurrent urinary stone formation. Patients with evidence or diagnosis of any coagulation disorder (including concomitant anti-coagulation therapy at enrollment). * Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease. * Patients with abnormal urologic conditions, including vesicoureteral reflux, bladder stones, bladder tumors and renal impairment. * Subjects with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>3 times the upper limit of normal. * Subjects with an albumin value \<3.0 g/dL. * Subjects with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders. * Subjects with active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment. * Subjects known to be colonized with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms. * Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids \[≤0.25 mg/kg prednisone or equivalent per day\] are permitted). * Any history of alcohol and/or drug abuse. * Current smoker. * Documented history of, or positive result of HIV, Hepatitis B or C, or any infectious disease. External signs, sequelae, or positive serology of sexually transmitted disease (including HPV). * Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study. * Concurrent participation in any other clinical investigation during the period of this investigation. Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study. * Any current illness that might confound the results of this investigation, including but not limited to bladder atonia, neuropathic/neurogenic bladder, bladder outlet obstruction (other than urethral stricture), sphincteric dysfunction, or spinal cord injury. * Any circumstance in which the investigator deems participation in the study is not in the subject's best interest. * Inability to participate in all necessary study activities due to physical or mental limitations. * Inability or unwillingness to return for all required follow-up visits. * inability or unwillingness to sign informed consent. * Patients requiring concomitant use of or treatment with immunosuppressive agents. * Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease).

Inclusion Criteria

Exclusion Criteria

* Stricture of the urethra meeting the following criteria:
* Patients must be available for all follow-up visits.
* Ability to speak English.

* Strictures of the meatus or prostatic urethra; any urethral stricture associated with or suspected to be urethral carcinoma, or strictures due to pelvic distraction injuries. Strictures \<10 mm or \>60 mm, as determined by urethrography, and criteria for bulbar urethral strictures excluding those with strictures \<20 mm and \>60 mm, as described by urethrography.
* Presence of untreated urinary tract infection.
* Presence or prior history of lichen sclerosis et atrophicus (previously termed 'balanitis xerotica obliterans').
* Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders.
* Any urological condition that would be likely to require additional urethral instrumentation during the period of investigation, including, but not limited to benign prostatic hyperplasia requiring treatment, use of alpha blockers, active prostate cancer, an unevaluated elevated prostate surface antigen (PSA), bladder cancer, or any recurrent urinary stone formation. Patients with evidence or diagnosis of any coagulation disorder (including concomitant anti-coagulation therapy at enrollment).
* Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease.
* Patients with abnormal urologic conditions, including vesicoureteral reflux, bladder stones, bladder tumors and renal impairment.
* Subjects with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>3 times the upper limit of normal.
* Subjects with an albumin value \<3.0 g/dL.
* Subjects with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders.
* Subjects with active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.
* Subjects known to be colonized with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms.
* Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids \[≤0.25 mg/kg prednisone or equivalent per day\] are permitted).
* Any history of alcohol and/or drug abuse.
* Current smoker.
* Documented history of, or positive result of HIV, Hepatitis B or C, or any infectious disease. External signs, sequelae, or positive serology of sexually transmitted disease (including HPV).
* Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study.
* Concurrent participation in any other clinical investigation during the period of this investigation. Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study.
* Any current illness that might confound the results of this investigation, including but not limited to bladder atonia, neuropathic/neurogenic bladder, bladder outlet obstruction (other than urethral stricture), sphincteric dysfunction, or spinal cord injury.
* Any circumstance in which the investigator deems participation in the study is not in the subject's best interest.
* Inability to participate in all necessary study activities due to physical or mental limitations.
* Inability or unwillingness to return for all required follow-up visits.
* inability or unwillingness to sign informed consent.
* Patients requiring concomitant use of or treatment with immunosuppressive agents.
* Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease).

Contacts and Locations

Study Contact

Mary-Clare Day, RN, BSN

CONTACT

336-713-1343

mday@wakehealth.edu

Principal Investigator

James Yoo, MD

PRINCIPAL_INVESTIGATOR

Wake Forest Institute for Regenerative Medicine

Study Locations (Sites)

University of California San Francisco

San Francisco, California, 94110

United States

Wake Forest Institute for Regenerative Medicine (WFIRM)

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

James Yoo, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Institute for Regenerative Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2029-12

Study Record Updates

Study Start Date2025-01

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

Urethral Stricture

Additional Relevant MeSH Terms

Urologic Diseases
Male Urogenital Diseases
Urethral Stricture
Urethral Injury