32 Participants Needed

D-Fi for Epidermolysis Bullosa

Recruiting at 3 trial locations
CM
Overseen ByChief Medical Officer, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Castle Creek Biosciences, LLC.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine whether administration of D-Fi in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Dystrophic Epidermolysis Bullosa.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug D-Fi differ from other treatments for epidermolysis bullosa?

D-Fi is unique because it targets the underlying genetic cause of recessive dystrophic epidermolysis bullosa (RDEB), which is a lack of type VII collagen, a protein crucial for skin integrity. Unlike other treatments that mainly address symptoms, D-Fi aims to address the root cause of the disease, potentially offering a more effective solution.12345

Are You a Good Fit for This Trial?

This trial is for children and adults aged 2 years or older with a clinical diagnosis of Recessive Dystrophic Epidermolysis Bullosa (RDEB) confirmed by COL7A1 genetic mutation. It's not suitable for those who are medically unstable, have certain infections like HIV or hepatitis, are allergic to the product's ingredients, have COL7 antibodies, systemic infections, or if they're pregnant or breastfeeding.

Inclusion Criteria

I am at least 2 years old.
I have RDEB confirmed by a COL7A1 genetic test.

Exclusion Criteria

I am too ill to travel to the research site.
I do not have HIV, hepatitis B, or hepatitis C.
Known allergy to any of the constituents of the product
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intradermal injections of D-Fi in treatment wounds during multiple sessions

48 weeks
Multiple visits at Day 1, Week 8, Week 16, and potentially at Week 26, Week 32, and Week 40

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term safety follow-up

Long-term safety follow-up for subjects who received D-Fi injections

15 years

What Are the Treatments Tested in This Trial?

Interventions

  • D-Fi
Trial Overview The study tests whether D-Fi alongside standard care improves wound healing in patients with Dystrophic Epidermolysis Bullosa compared to just standard care. Participants will be divided into two groups: one receiving the new treatment plus standard care and another receiving only the standard care.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: D-Fi COL7A1 Genetically-Corrected Autologous FibroblastsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Castle Creek Biosciences, LLC.

Lead Sponsor

Trials
12
Recruited
680+

Prosoft Clinical

Collaborator

Trials
9
Recruited
910+

Citations

Deconstructing progressive inflammatory fibrosis in recessive dystrophic epidermolysis bullosa. [2021]
Patient-reported outcomes and quality of life in recessive dystrophic epidermolysis bullosa: A global cross-sectional survey. [2022]
[Dystrophic epidermolysis bullosa: surgical treatment of advanced hand deformities]. [2006]
A comprehensive next-generation sequencing assay for the diagnosis of epidermolysis bullosa. [2018]
Itch in recessive dystrophic epidermolysis bullosa: findings of PEBLES, a prospective register study. [2023]
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