10 Participants Needed

Bioengineered Penile Tissue for Penile Damage

MD
Overseen ByMary-Clare Day, RN, BSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressive agents, you may not be eligible to participate.

What data supports the effectiveness of the treatment Autologous Tissue Engineered Corpora for penile damage?

Research in rabbits showed that bioengineered penile tissue, made from the body's own cells, can successfully replace damaged tissue and restore normal function, including the ability to impregnate females. This suggests the treatment could be effective for penile reconstruction in humans.12345

Is bioengineered penile tissue safe for use in humans?

Research on bioengineered penile tissue, primarily conducted in animal models like rabbits, shows promising safety results, with no signs of immunological rejection and good compatibility with existing tissues. These studies suggest that the technology could be safe for penile reconstruction, but more research in humans is needed to confirm this.12367

How is the treatment Autologous Tissue Engineered Corpora different from other treatments for penile damage?

This treatment is unique because it uses bioengineered penile tissue created from the patient's own cells, which are grown on a collagen matrix to replace damaged penile tissue. Unlike traditional implants, this approach aims to restore both the structure and function of the penis, potentially allowing for normal reproductive, sexual, and urinary functions.12358

What is the purpose of this trial?

The primary objective of this clinical trial is to evaluate the safety of autologous engineered corpora cavernosa + albuginea constructs for treatment of complex penile deformities. Autologous endothelial and smooth muscle cells obtained from enrolled subjects' corpora cavernosa biopsy sample, will be culture expanded in vitro and used to seed decellularized corpora cavernosa + albuginea obtained from cadaveric-donors to create autologous bioengineered corpora cavernosa/albuginea constructs for repair of damaged penile tissues.

Research Team

RP

Ryan P Terlecki, MD

Principal Investigator

Associate Professor

Eligibility Criteria

Men aged 18-60 with stable penile deformities due to trauma, infection, or other causes who've unsuccessfully tried conventional treatments. They must be healthy enough for surgery, not have severe bleeding disorders or unstable heart conditions, and can't be immunocompromised or have certain infections like HIV.

Inclusion Criteria

Deformities less than 5 cm in length
Written informed consent obtained prior to participation in the study
I tried standard treatments for my condition over 6 months ago without success.
See 4 more

Exclusion Criteria

I haven't had serious lung problems or needed a nebulizer in the last 6 months.
I haven't had any serious heart problems in the last 6 months.
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
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy and Cell Expansion

Participants undergo a corpora cavernosum biopsy to obtain endothelial and smooth muscle cells, which are then culture expanded in vitro.

3-4 weeks

Transplantation

The engineered construct, including corporal tissue with attached tunica, is transplanted into the surgically prepared site of penile injury.

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for graft thrombosis or failure and treatment-related adverse events.

36 months

Treatment Details

Interventions

  • Autologous Tissue Engineered Corpora
Trial Overview The trial is testing a new method where damaged penile tissue is repaired using bioengineered constructs made from the patient's own cells grown on donor tissue. This could help men with complex penile deformities that haven't improved with standard treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Autologous tissue engineered corporaExperimental Treatment1 Intervention
All subjects enrolled will undergo a corpora cavernosum biopsy. Endothelial and smooth muscle cells will be isolated and expanded, then seeded onto a scaffold that will later be implanted into the subject.

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+

References

Engineering of erectile tissue: the state and future of corporal restoration. [2021]
Bioengineered corporal tissue for structural and functional restoration of the penis. [2022]
[Reconstruction of penile function with tissue engineering techniques]. [2007]
Autologous penile corpora cavernosa replacement using tissue engineering techniques. [2017]
New perspectives of penile enhancement surgery: tissue engineering with biodegradable scaffolds. [2005]
Functional reconstruction of injured corpus cavernosa using 3D-printed hydrogel scaffolds seeded with HIF-1α-expressing stem cells. [2021]
Reconstitution of human corpus cavernosum smooth muscle in vitro and in vivo. [2006]
Co-culture of smooth muscle cells and endothelial cells on three-dimensional bioprinted polycaprolactone scaffolds for cavernosal tissue engineering. [2022]
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