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Tests treatment safety and results for Urologic Diseases
Official title Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures
ClinicalTrials.gov ID: NCT03258658
What this study is testing
What is Autologous Engineered Urethral Construct?
Autologous Engineered Urethral Construct is an investigational medicine, being studied as a potential treatment for urologic diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75, men only
You may be able to join if
- Stricture of the urethra meeting the following criteria: a) History of at least one 15-60 mm in length, as determined by urethrography. c) Contains...
- Patients must be available for all follow-up visits.
- Ability to speak English.
You likely can't join if
- Strictures of the meatus or prostatic urethra; any urethral stricture associated with or suspected to be urethral carcinoma, or strictures due to...
- 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...
- Any urological condition that would be likely to require additional urethral instrumentation during the period of investigation, including, but not...
- Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease.
See the full eligibility criteria
- Stricture of the urethra meeting the following criteria: a) History of at least one 15-60 mm in length, as determined by urethrography. c) Contains at least 1 strictured segment through which a 16 Fr flexible cystoscope...
- 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 \ 60 mm, as determined by...
- 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...
- 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.
- people with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>3 times the upper limit of normal.
- people with an albumin value \<3.0 g/dL.
- people with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders.
- people with active tuberculosis (TB) requiring treatment in the past 3 years. people with a current positive (≥5 mm induration for high-risk people; otherwise ≥10 mm of induration) purified protein derivative (PPD) test...
- people known to be colonized with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms.
- Immunocompromised people or people 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...
- 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...
- 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)...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.