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Monoclonal Antibodies
Penile Transplant for Traumatic Amputation
Phase 2 & 3
Recruiting
Led By Richard Redett, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Donor: Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure)
Recipient: Must have completed a clinic appointment with one of the study surgeons to discuss all penile reconstructive options
Timeline
Screening 3 weeks
Treatment Varies
Follow Up transplantation through end of study period ( 5 years)
Awards & highlights
Study Summary
This trial will study the effects of a cell-based immunomodulatory protocol for penile allotransplantation. The goal is to demonstrate superior outcomes compared to satisfaction and quality of life in conventional phalloplasty patients.
Who is the study for?
This trial is for males aged 18-69 who have lost most of their penis due to injury or cancer. Donors must be brain-dead, a blood type match, stable without strong drugs to maintain blood pressure, and with family consent. Recipients should closely match the donor's skin tone.Check my eligibility
What is being tested?
The study tests penile allotransplantation using immunosuppression (tacrolimus) and humanized anti-CD52 antibodies. It aims to achieve graft survival with reduced immunosuppression and compare outcomes with traditional reconstructions in terms of function and quality of life.See study design
What are the potential side effects?
Potential side effects include those related to immunosuppressants like tacrolimus such as increased infection risk, possible organ damage, diabetes, high blood pressure, and nervous system issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My donor's blood pressure is stable without needing a lot of medication.
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I have met with a study surgeon to discuss penile reconstruction options.
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I am a male aged between 16 and 65.
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I am a man aged between 18 and 69.
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I have lost most of my penis due to an injury in the last 6 months or earlier.
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I had surgery to remove my penis due to cancer.
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My blood type matches the recipient's.
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I have been cancer-free for the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ transplantation through end of study period ( 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~transplantation through end of study period ( 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Allograft Survival
Secondary outcome measures
Brief Pain Inventory (Short Form) ) (BPISF)
Modified Sexual Life Quality Questionnaire-Quality of Life (mSLQQ- QoL)
Psychological Measures by Satisfaction with Life Scale (SWLS)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment: TransplantationExperimental Treatment3 Interventions
Penile transplantation with an immunomodulatory protocol consisting of monoclonal antibody induction therapy of humanized anti CD52 followed by donor bone marrow infusion and tacrolimus monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,720 Total Patients Enrolled
Richard Redett, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active tuberculosis.I was diagnosed with cancer within the last 5 years.I have paralysis due to a stroke or injury.I have a genetic condition that affects my nerves.My donor's blood pressure is stable without needing a lot of medication.I have met with a study surgeon to discuss penile reconstruction options.I agree to provide samples for testing and receive bone marrow infusion.I have been diagnosed with viral encephalitis.I have toxoplasmosis.I have nerve damage due to an infection or inflammation.I have nerve damage from previous treatments.I have mixed connective tissue disease.I have severe joint damage in my limb due to arthritis.I had surgery to remove my penis due to cancer.I have high levels of HLA antibodies.I don't have any genetic disorders that affect blood clotting.I am a male aged between 16 and 65.I am a man aged between 18 and 69.I have lost most of my penis due to an injury in the last 6 months or earlier.I have survived penile cancer for more than 5 years.I agree to follow the treatment plan and am committed to the immunotherapy.I have an active Hepatitis B infection.I have an untreated infection in my blood.I have Hepatitis C.My blood type matches the recipient's.I am HIV positive.I have been cancer-free for the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: Transplantation
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Just curious, how many people are included in this test group?
"The clinicaltrials.gov website says that this study is taking in new participants. This trial was originally posted on June 1, 2014, with the latest update happening on August 23, 2022. They are looking for a total of 60 people, at just 1 site."
Answered by AI
Are there specific eligibility requirements to join this clinical trial?
"This medical study is open to 60 male patients that have undergone urologic surgery. Participants must be aged between 18 and 69, and must meet the following criteria: have a family member that is willing to donate their penis for the graft, have lost at least 75% of their phallus to an injury (recent or remote), or have had a penectomy due to penile cancer."
Answered by AI
Does this research project seek out elderly participants?
"The age range for individuals that this trial is recruiting is between 18-69 years old."
Answered by AI
What is the typical reason that Penile Allotransplantation is employed?
"Penile Allotransplantation is commonly used to mitigate the effects of dermatitis, atopic. Additionally, this treatment can also ameliorate symptoms for transplant rejection (liver and kidney), as well as psoriasis."
Answered by AI
Are there other successful cases of Penile Allotransplantation?
"Out of the 154 clinical trials currently underway, 18 are in Phase 3. Many of these investigations are based in Philadelphia, Pennsylvania; however, there are 872 locations worldwide where research is being conducted."
Answered by AI
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