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Engineered Urethral Tissue for Urethral Stricture
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Autologous Engineered Urethral Construct
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Has Autologous Engineered Urethral Construct obtained clearance from the FDA?
"As this is a Phase 1 trial, with limited clinical data to support its safety and efficacy, our team at Power rated the Autologous Engineered Urethral Construct's security as a 1 on their scale."
Is this investigation still recruiting participants?
"The information found on clinicaltrials.gov suggests that this medical trial no longer is accepting patients; the study was originally posted in December of 2022 and last modified October 26th, 2022. Despite not currently recruiting, there are 248 other clinical studies still open to participants."
What criteria must be met to enroll in this research endeavor?
"This research is seeking 10 individuals aged 21 to 65 with urologic diseases and meeting the following criteria: A strictured segment through which a 16 Fr flexible cystoscope cannot be passed, availability for all follow-up visits, history of at least one failed conservative management attempt minimum 6 months prior."
Does the research team consider applicants aged 45 and above for inclusion in this trial?
"This trial demands that prospective participants are between 21 and 65 years old. Other trials exist for under 18s (26) or seniors over the age of 65 (237)."
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