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Tissue Engineering
Engineered Urethral Tissue for Urethral Stricture
Phase 1
Waitlist Available
Led By James Yoo, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Contains at least 1 strictured segment through which a 16 Fr flexible cystoscope cannot be atraumatically passed
Urethral stricture of 10-60 mm in length, as determined by urethrography
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monitored through 36 months post treatment
Awards & highlights
Study Summary
This trial is to test if using a person's own cells to create a urethral construct is safe and effective in treating urethral strictures in adult males.
Who is the study for?
Adult males with urethral strictures who have had at least one failed conservative treatment, a stricture length of 10-60 mm, and can't pass a cystoscope. Excluded are those with certain skin conditions, bleeding or coagulation disorders, low albumin levels, neurological issues like MS or Parkinson's disease, untreated UTIs, systemic diseases like HIV or diabetes, recent other trial participation or investigational drug use within 30 days.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of autologous engineered urethral constructs in men. It involves taking cells from the patient's bladder to create a tissue-engineered tube for repairing urethral strictures. This Phase I trial is non-randomized and uncontrolled at a single center.See study design
What are the potential side effects?
Potential side effects may include complications related to surgery such as infection risk increase due to implanting biological material; pain or discomfort at cell harvest site; possible immune reaction; and failure of the construct leading to additional medical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a narrow area in my body that a small medical scope cannot pass through without causing damage.
Select...
I have a urethral blockage between 10-60 mm long.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ monitored through 36 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monitored through 36 months post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of product-related, biopsy procedure-related, and injection procedure-related adverse events
Secondary outcome measures
Effectiveness of urethral construct in repairing urethral stricture
Trial Design
1Treatment groups
Experimental Treatment
Group I: Autologous Engineered Urethral ConstructExperimental Treatment1 Intervention
All subjects enrolled will undergo a full-thickness bladder biopsy as an out-patient surgical procedure. Urothelial and Smooth Muscle Cells recovered from the biopsy will be isolated and expanded over the next 4-6 weeks, and then seeded onto a tubular scaffold to create the autologous engineered urethral construct. Subjects will undergo a second surgical procedure to excise the urethral stricture and implant the urethral construct. All subjects will be followed for 3 years for safety and efficacy.
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Who is running the clinical trial?
United States Department of DefenseFED
870 Previous Clinical Trials
327,710 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,250 Previous Clinical Trials
1,007,143 Total Patients Enrolled
James Yoo, MDPrincipal InvestigatorWake Forest Institute for Regenerative Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a bleeding disorder with low platelets or need regular blood products.I do not have any ongoing urinary or prostate issues that would need treatment during the study.My kidney function is impaired.You have a history of alcohol or drug abuse.I currently have an untreated urinary tract infection.I am immunocompromised or take low-dose immunosuppressive medication.I do not have any illnesses that could affect the study results, such as bladder or nerve issues.I am currently using or need immunosuppressive medication.I have a neurological disorder like multiple sclerosis or Parkinson's disease.I have a narrow area in my body that a small medical scope cannot pass through without causing damage.You are currently smoking cigarettes.I am unable or unwilling to attend all required follow-up visits.I have a urethral blockage between 10-60 mm long.I cannot do all study activities because of my health or mental condition.I do not have uncontrolled diabetes or unstable heart/lung conditions.I have or had lichen sclerosus.I have a narrow urethra and treatments haven't worked for at least 6 months.I have a blood clotting disorder or am on blood thinners.I am known to carry MRSA, VRE, or gentamicin-resistant bacteria.Your albumin level is lower than 3.0 g/dL.Your liver enzyme levels (ALT or AST) are more than three times the normal limit.I haven't had active TB needing treatment in the last 3 years and have no current TB infection.I have a urinary system condition like kidney issues or bladder problems.You have narrow passages in your urethra that are shorter than 20 mm or longer than 60 mm.I have narrowing in my urethra not caused by cancer or severe injury.I have a history or positive test for HIV, Hepatitis B or C, or any infectious disease.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous Engineered Urethral Construct
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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