Bioengineered Penile Tissue for Penile Damage

Recruiting in Palo Alto (17 mi)

Overseen byRyan P Terlecki, MD

Age: 18 - 65

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

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.

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

Ability to speak English

Written informed consent obtained prior to participation in the study

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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

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Treatment Details

Interventions

Autologous Tissue Engineered Corpora (Tissue Engineering)

Trial OverviewThe 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.