10 Participants Needed

Engineered Urethral Tissue for Urethral Stricture

Recruiting at 1 trial location
MD
Overseen ByMary-Clare Day, RN, BSN
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive agents or certain treatments for urological conditions, you may not be eligible to participate.

What data supports the effectiveness of the treatment Autologous Engineered Urethral Construct for urethral stricture?

Research shows that using a patient's own cells to create engineered urethral tissue can help manage long and complex urethral strictures, potentially preventing them from coming back. This approach has been tested in patients needing urethral reconstruction and has shown promise in repairing urethral defects.12345

Is the engineered urethral tissue treatment safe for humans?

The safety of engineered urethral tissue treatments has been studied, and they are considered promising for managing urethral strictures. These treatments use the patient's own cells, which may reduce the risk of rejection and complications, suggesting they are generally safe for human use.12346

How is the treatment Autologous Engineered Urethral Construct different from other treatments for urethral stricture?

This treatment uses the patient's own cells to create a new urethral tissue, which can help prevent the recurrence of strictures (narrowing of the urethra) and offers a more natural and potentially longer-lasting solution compared to traditional surgical methods that often involve grafts or flaps.12378

Research Team

JY

James Yoo, MD

Principal Investigator

Wake Forest Institute for Regenerative Medicine

Eligibility Criteria

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.

Inclusion Criteria

Patients must be available for all follow-up visits
I have a narrow area in my body that a small medical scope cannot pass through without causing damage.
I have a urethral blockage between 10-60 mm long.
See 2 more

Exclusion Criteria

Inability or unwillingness to sign informed consent
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.
See 24 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Biopsy and Cell Expansion

Participants undergo a full-thickness bladder biopsy to obtain urothelial and smooth muscle cells, which are then cultured and expanded over 4-6 weeks.

4-6 weeks
1 visit (in-person) for biopsy

Surgical Implantation

Participants undergo surgical removal of the urethral stricture and implantation of the autologous engineered urethral construct.

1 week
1 visit (in-person) for surgery

Follow-up

Participants are monitored for safety and effectiveness of the urethral construct, including improvement in peak urinary flow rate and adverse events.

36 months
Regular follow-up visits (in-person)

Treatment Details

Interventions

  • Autologous Engineered Urethral Construct
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Findings from Research

Autologous engineered urethral constructs show promise as a treatment for long and complex urethral strictures, potentially offering a definitive solution.
This approach may help eliminate the recurrence of strictures, which is a common issue with traditional treatments.
Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures: Clinical Trial Update.Ghaffar, U., Terlecki, R., Yoo, JJ., et al.[2023]
Tissue-engineered urethras created from patients' own cells have been shown to be effective for urethral reconstruction, remaining functional for up to 6 years in a study involving 5 boys with urethral defects.
The engineered urethras maintained normal architecture and wide calibers without strictures, indicating promising long-term outcomes for patients needing complex urethral repairs.
Tissue-engineered autologous urethras for patients who need reconstruction: an observational study.Raya-Rivera, A., Esquiliano, DR., Yoo, JJ., et al.[2022]
The study successfully engineered cartilage stents using chondrocytes and polymer scaffolds, demonstrating their potential for treating urethral or ureteral stricture disease.
Both in vitro and in vivo tests showed that these stents exhibited desirable properties, such as elasticity and the ability to withstand pressure, along with confirmed cartilage formation and collagen deposition, indicating their biocompatibility and mechanical durability.
Tissue engineered stents created from chondrocytes.Amiel, GE., Yoo, JJ., Kim, BS., et al.[2019]

References

Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures: Clinical Trial Update. [2023]
Tissue-engineered autologous urethras for patients who need reconstruction: an observational study. [2022]
Tissue engineered stents created from chondrocytes. [2019]
Urethral reconstruction with autologous urine-derived stem cells seeded in three-dimensional porous small intestinal submucosa in a rabbit model. [2018]
Tissue engineering of the urethra: where are we in 2019? [2021]
6.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Urethra Reconstruction with Tissue-Engineering Technology]. [2022]
Regenerative and engineered options for urethroplasty. [2022]
The potential role of tissue-engineered urethral substitution: clinical and preclinical studies. [2022]