Your session is about to expire
← Back to Search
Gene Therapy
FCX-007 for Epidermolysis Bullosa (DEFI-RDEB Trial)
Phase 3
Waitlist Available
Research Sponsored by Castle Creek Biosciences, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
DEFI-RDEB Trial Summary
This trial will compare FCX-007 to a control group to see if it improves wound healing in people with a rare skin condition.
Who is the study for?
This trial is for children and adults over 2 years old with Recessive Dystrophic Epidermolysis Bullosa (RDEB) confirmed by a specific genetic mutation. Participants must not have certain infections, antibodies, or cancer history at the treatment site, nor can they be pregnant or breastfeeding. They shouldn't have used other RDEB treatments in the last three months.Check my eligibility
What is being tested?
The study tests if FCX-007 (dabocemagene autoficel), alongside usual care, improves wound healing compared to standard care alone in those with RDEB. The FDA's Office of Orphan Products Development funds this research.See study design
What are the potential side effects?
While specific side effects for FCX-007 are not listed here, gene therapies like it may cause immune reactions, discomfort at injection sites, and potential long-term risks which will be monitored throughout the trial.
DEFI-RDEB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have RDEB confirmed by a COL7A1 genetic test.
DEFI-RDEB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Wound Closure of the First Wound Pair at Week 24
Secondary outcome measures
Complete Wound Closure of All Wound Pairs at Week 12
Complete Wound Closure of All Wound Pairs at Week 24
Complete Wound Closure of the First Wound Pair at Week 12
DEFI-RDEB Trial Design
1Treatment groups
Experimental Treatment
Group I: FCX-007 COL7A1 Genetically-Corrected Autologous FibroblastsExperimental Treatment1 Intervention
Intra-subject randomized (paired wounds in each subject receive experimental treatment, FCX-007, or remain untreated). Up to three target wound pairs will be identified for each subject. Following pairing, target wounds will be randomly assigned as the treatment wound (FCX-007 is administered) or control wound. Subjects will receive intradermal injections of FCX-007 in each specified treatment wound in two or more treatment sessions. The first treatment session occurs at Day 1 and the second at Week 12/Month 3. Additional treatment sessions may occur at Week 24/Month 6 and Week 36/Month 9 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated.
Find a Location
Who is running the clinical trial?
Castle Creek Biosciences, LLC.Lead Sponsor
10 Previous Clinical Trials
639 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to any of the ingredients in the product.My body has COL7 antibodies.I have had squamous cell carcinoma where I will get injections.I do not have an active infection with HIV, hepatitis B, or hepatitis C.I am too unwell to travel to the research location.I have an infection that affects my whole body.I am currently pregnant or breastfeeding.I have or had metastatic squamous cell carcinoma.I am at least 2 years old.I haven't received any specific chemical or biological treatment for RDEB in the last 3 months.I have RDEB confirmed by a COL7A1 genetic test.
Research Study Groups:
This trial has the following groups:- Group 1: FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts
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.
In how many distinct places is this research being conducted?
"Currently, there are 5 enrolment sites for this study with more planned in the future. These sites are in Rochester, Aurora, Jacksonville, and other as-of-yet undisclosed locations. If you are considering enrolling in this trial, please pick the site that is most geographically convenient for you to reduce travel burden."
Answered by AI
Does the FDA sanction the use of FCX-007 (dabocemagene autoficel)?
"FCX-007 (dabocemagene autoficel) has received a safety score of 3. This is due to Phase 3 trials having evidence of efficacy as well as multiple rounds of data supporting safety."
Answered by AI
Are there still opportunities for people to enroll in this research?
"According to clinicaltrials.gov, this study is not presently looking for new participants. The trial was initially posted on 2020-06-09 and was last updated on 2022-08-10. Although this clinical trial is not enrolling candidates at this time, there are 29 other clinical trials that are."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger