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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monitored through 36 months post-treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a man between 18 and 60 years old.
Select...
I have diagnosed damage to the penis due to injury, infection, swelling, or fibromatosis.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
Number of participants with graft thrombosis or grant failures
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,173 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,184 Total Patients Enrolled
Ryan P Terlecki, MDPrincipal InvestigatorAssociate Professor
1 Previous Clinical Trials
8 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I tried standard treatments for my condition over 6 months ago without success.I do not have a bleeding disorder with low platelets or need regular blood products.My kidney function is impaired with high creatinine levels.I have a weakened immune system or am taking medication that lowers my immunity.I cannot do all required study activities due to health or mental reasons.I currently have a urinary tract infection that hasn't been fully treated.I have a neurological disorder like multiple sclerosis or Parkinson's disease.I am a man between 18 and 60 years old.I have diagnosed damage to the penis due to injury, infection, swelling, or fibromatosis.My diabetes is not under control, with an HbA1C over 9%.I have an infection resistant to common antibiotics.I have a history of infectious diseases like HIV, Hepatitis B or C, or any STDs that might affect my study participation.I have had a stable condition for over 6 months without pain or changes.I need to take medication that weakens my immune system.I haven't had active TB needing treatment in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous tissue engineered corpora
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does Autologous tissue engineered corpora impact one's well-being?
"Due to the limited data concerning efficacy and safety, autologous tissue engineered corpora received a score of 1 on our risk scale."
Answered by AI
Is enrollment for this scientific research still available?
"Unfortunately, the clinicaltrials.gov platform shows that this trial is not presently open for recruitment; its last update was on August 23rd 2022. Nevertheless, there are 391 other trials actively seeking participants at present time."
Answered by AI
Am I eligible to enroll in this clinical research effort?
"This medical study is seeking 10 individuals aged 18 to 60 with diagnosed urologic conditions. They must be present for all subsequent visits, have corpora cavernosum structural irregularities caused by trauma, infection, inflammation or fibromatosis (confirmed by clinical examination and/or imaging), and their deformities must not exceed 5 cm in length without any discomfort or changes for the past 6 months at least."
Answered by AI
Does this clinical experiment include elderly participants aged 70 or more?
"This clinical trial is on the lookout for participants aged 18 or higher, yet not exceeding 60 years of age."
Answered by AI
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