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

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.

Conditions

Dystrophic Epidermolysis Bullosa

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Dystrophic Epidermolysis Bullosa
Intervention / Treatment

-

Contacts and Locations

Redwood City

Stanford University School of Medicine, Dermatology, Redwood City, California, United States, 94063

Santa Margarita

Mission Dermatology, Santa Margarita, California, United States, 92688

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Worcester

University of Massachusetts, Worcester, Massachusetts, United States, 01655

Philadelphia

Thomas Jefferson University Dept of Dermatology and Cutaneous Biology, Philadelphia, Pennsylvania, United States, 19107

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female ≥2 years of age at the Screening visit
  • * Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation.
  • * Medical instability limiting ability to travel to the investigative site.
  • * Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.
  • * The presence of COL7 antibodies.
  • * Evidence of systemic infection.
  • * Known allergy to any of the constituents of the product.
  • * Female who is pregnant or breastfeeding.

Ages Eligible for Study

2 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Castle Creek Biosciences, LLC.,

Study Record Dates

2042-02