RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Dabocemagene Autoficel (D-Fi; FCX-007; Genetically Modified Autologous Human Dermal Fibroblasts) for the Treatment of Wounds Due to Dystropic Epidermolysis Bullosa

Quick Facts

Study Start:2025-03
Study Completion:2042-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06892639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ≥2 years of age at the Screening visit
  2. * Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation.
  1. * Medical instability limiting ability to travel to the investigative site.
  2. * Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.
  3. * The presence of COL7 antibodies.
  4. * Evidence of systemic infection.
  5. * Known allergy to any of the constituents of the product.
  6. * Female who is pregnant or breastfeeding.

Contacts and Locations

Study Contact

Chief Medical Officer, MD
CONTACT
484-352-3055
medinfo@castlecreekbio.com

Study Locations (Sites)

Stanford University School of Medicine, Dermatology
Redwood City, California, 94063
United States
Mission Dermatology
Santa Margarita, California, 92688
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
University of Massachusetts
Worcester, Massachusetts, 01655
United States
Thomas Jefferson University Dept of Dermatology and Cutaneous Biology
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Castle Creek Biosciences, LLC.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03
Study Completion Date2042-02

Study Record Updates

Study Start Date2025-03
Study Completion Date2042-02

Terms related to this study

Keywords Provided by Researchers

  • DEB

Additional Relevant MeSH Terms

  • Dystrophic Epidermolysis Bullosa