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Gene Therapy
EB-101 for Epidermolysis Bullosa
Phase 3
Recruiting
Research Sponsored by Abeona Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Two confirmed RDEB C7 mutations with recessive inheritance patterns (or confirmation that parents don't have any evidence of dominant disease)
Must have at least one wound site that meets all of the following criteria: An area ≥20 cm2, Present for ≥6 months, Stage 2 wound defined as an open skin wound with partial thickness loss of dermis that has not extended through the dermis into subcutaneous tissue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial studies the safety of a new treatment for wounds in people with a certain skin disorder.
Who is the study for?
This trial is for patients aged 6 and older with Recessive Dystrophic Epidermolysis Bullosa (RDEB) who have stable pain medication regimens and at least one wound larger than 20 cm2 that's been present for over six months. Participants must not be pregnant, use reliable birth control, and cannot have a history of certain allergies or recent investigational therapies.Check my eligibility
What is being tested?
The trial tests EB-101, which are engineered skin sheets applied surgically to treat wounds caused by RDEB. It aims to assess the safety of this treatment in both new patients and those previously treated with EB-101.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include reactions related to surgery, anesthesia complications, infection risk at the wound site, or possible immune responses against the introduced C7 protein.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have two confirmed RDEB C7 mutations inherited recessively.
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I have a wound larger than 20 cm2, present for over 6 months, and it's a stage 2 wound.
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I can safely receive anesthesia for EB-101 treatment.
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I have been diagnosed with RDEB.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety Endpoint
Safety Endpoint (Incidence of squamous cell carcinoma)
Safety Endpoint (number of patients and wounds that have an infection or any related adverse event.)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: EB-101 Surgical application of RDEB woundsExperimental Treatment1 Intervention
New or Previously Treated RDEB Patients
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Who is running the clinical trial?
Abeona Therapeutics, IncLead Sponsor
11 Previous Clinical Trials
1,089 Total Patients Enrolled
Dmitriy Grachev, MD, PhDStudy DirectorAbeona Therapeutics, Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have two confirmed RDEB C7 mutations inherited recessively.I have a wound larger than 20 cm2, present for over 6 months, and it's a stage 2 wound.I have severe symptoms or lab results, but common issues like throat tightness, low iron, low protein, or pain/itch won't disqualify me.I am too unwell to travel for treatment or participate in the study.You are currently addicted to drugs or alcohol.You have shown an immune response to C7 in a blood test.I am using reliable birth control and have a negative pregnancy test.I have an infection that affects my whole body.I am 6 years old or older.I can safely receive anesthesia for EB-101 treatment.You are allergic to vancomycin or amikacin.I haven't had experimental treatments for RDEB in the last 3 months.I cannot or do not want to provide tissue samples for testing.I have been diagnosed with RDEB.I have been on the same pain medication for at least 30 days.You have high levels of a specific protein in your skin.I have or had squamous cell carcinoma in the area where EB-101 will be applied.You have a medical condition, like HIV, hepatitis B, or hepatitis C, that could make it unsafe for you to take part in the study.
Research Study Groups:
This trial has the following groups:- Group 1: EB-101 Surgical application of RDEB wounds
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has the FDA sanctioned EB-101 for treatment of Recessive Dystrophic Epidermolysis Bullosa lesions?
"According to our team, EB-101 Surgical application of RDEB wounds is rated a 3 on the safety scale. This score was given due to the fact that there has been proof efficacy and multiple rounds of data collected supporting its security."
Answered by AI
Is enrollment available right now for this experiment?
"According to information posted on clinicaltrials.gov, this trial is not in the recruitment phase at present. The study was initially published on March 24th 2023 and has most recently been updated February 13th 2023. Despite this current lack of enrolment opportunity, there are currently 24 other medical studies open for patient participation."
Answered by AI
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