Evaluation of D-Fi for the Treatment of Wounds Due to DEB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2042-02-28

Brief Summary

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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.

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Detailed Description

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CCB-EB-304 is a multi-center, intra-patient randomized and controlled, open-label, rater-blinded Phase 3 study of D-Fi for the treatment of persistent non-healing and recurrent DEB wounds in approximately 32 subjects. Each subject will serve as his/her own control. Each subject's Target Wounds will be paired then randomized to receive D-Fi (Treatment Wound) or remain untreated (Control Wound). One Target Wound Pair will be identified for each subject.

Subjects will receive intradermal injections of D-Fi in each specified Treatment Wound in three or more treatment sessions. The first treatment session occurs at Day 1, the second at Week 8/Month 2 and the third at Week 16/Month 4. Additional treatment sessions may occur at Week 26/Month 6 and Week 32/Month 8 and Week 40/Month 10 when unclosed Treatment Wounds may be re-treated, and unclosed Control Wounds may be treated. Safety and efficacy assessments will occur at scheduled intervals through Week 48/Month 12, when the Treatment Period is completed, and is followed by an optional Open-Label Extension (OLE) treatment phase of an additional 96 weeks. A long-term safety follow-up period (through 15 years) commences for subjects who have received one or more D-Fi injections, either following the treatment phase or if the subject had opted-in, the OLE.

Conditions

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Dystrophic Epidermolysis Bullosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intra-patient Randomized and Controlled, Open-label, Rater-Blinded, Multi-center

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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D-Fi COL7A1 Genetically-Corrected Autologous Fibroblasts

Intra-subject randomized (paired wounds in each subject receive experimental treatment, D-Fi, or remain untreated). One target wound pair will be identified for each subject. Following pairing, target wounds will be randomly assigned as the treatment wound (D-Fi is administered) or control wound. Subjects will receive intradermal injections of D-Fi in each specified treatment wound in two or more treatment sessions. The first treatment session occurs at Day 1, the second at Week 8/Month 2 and the third at Week 16/Month 4. Additional treatment sessions may occur at Week 26/Month 6, Week 32/Month 8 and Week 40/Month 10 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated.

Group Type EXPERIMENTAL

D-Fi

Intervention Type BIOLOGICAL

D-Fi is composed of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen.

Interventions

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D-Fi

D-Fi is composed of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥2 years of age at the Screening visit
* Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation.

Exclusion Criteria

* Medical instability limiting ability to travel to the investigative site.
* Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.
* The presence of clinically significant COL7 antibodies.
* Evidence of systemic infection.
* Known allergy to any of the constituents of the product.
* Female who is pregnant or breastfeeding.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No