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Tissue Engineering

Bioengineered Penile Tissue for Penile Damage

Phase 1

Waitlist Available

Led By Ryan P Terlecki, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males aged 18-60 years

Acquired structural abnormalities of the corpora cavernosum secondary to trauma, infection, inflammation, or fibromatosis diagnosed by clinical examination, ultrasound, or computerized tomography

Must not have

Unstable pulmonary disorders within the past 6 months including dyspnea on exertion, chronic productive cough, pneumonia, hemoptysis, asthma requiring nebulized therapy

Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia, or patients routinely receiving blood products for bleeding disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monitored through 36 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it is safe to use a person's own cells to repair damage to the penile tissue.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications at the biopsy site, immune reactions to implanted tissues, infection risks from surgery, and possible failure of the construct leading to additional corrective procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man between 18 and 60 years old.

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I have diagnosed damage to the penis due to injury, infection, swelling, or fibromatosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had serious lung problems or needed a nebulizer in the last 6 months.

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I do not have a bleeding disorder with low platelets or need regular blood products.

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My kidney function is impaired with high creatinine levels.

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I have a weakened immune system or am taking medication that lowers my immunity.

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I cannot do all required study activities due to health or mental reasons.

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I currently have a urinary tract infection that hasn't been fully treated.

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I have an infection resistant to common antibiotics.

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I have a neurological disorder like multiple sclerosis or Parkinson's disease.

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I need to take medication that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monitored through 36 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monitored through 36 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and monitored through 36 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary study objectives

Number of participants with graft thrombosis or grant failures

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met