D-Fi for Epidermolysis Bullosa

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Castle Creek Biosciences, LLC.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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

+3 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: D-Fi COL7A1 Genetically-Corrected Autologous FibroblastsExperimental Treatment1 Intervention

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.