Study of Immune Tolerance and Capacity for Wound Healing of Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Status: Completed
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

Recessive Dystrophic Epidermolysis Bullosa (RDEB) is one of the most severe rare inherited skin disorders affecting children and adults. Current medical care protocols for RDEB patients are limited to palliative procedures to treat blistering and erosive lesions, wounds, and severe local and systemic complications such as fusion and contracture of the digits, skin cancer, esophageal stricture, severe anemia, infections, malnutrition and growth retardation. However, current medical treatments still cannot prevent the recurrence of the lesions arising from defective expression of type VII collagen (COL7A1), the main constituent of anchoring fibrils which form essential structures for dermal-epidermal adherence. The purpose of this study is to investigate the capacity of keratinocytes and fibroblasts to repair skin wounds in patients suffering from Recessive Dystrophic Epidermolysis Bullosa (RDEB).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 65
Healthy Volunteers: f
View:

• Confirmed molecular diagnosis of recessive dystrophic epidermolysis bullosa, established for both alleles;

• Non severe generalized clinical form of RDEB;

• Presence of type VII collagen on skin biopsy and/or western-blot analysis detected with a set of specific antibodies;

• Presence of intact skin areas without blisters, infection or erosion;

• Absence of hospitalization related to EB condition;

• Patients and their parents when applicable should be able and willing to return for follow up;

• Patients should be able and willing to give signed informed consent. For patients who are minor, informed consent will be signed by a legally authorized representative, as well as an assent form by the minor patient.

• Ability to undergo local anesthesia.

Locations
Other Locations
France
Inserm U781 Service de Génétique Necker Hospital for sick children
Paris
Service de dermatologie Necker Hospital for sick children
Paris
United Kingdom
Guy's and ST Thomas NHS Foundation trust/Guy's Hospital
London
Time Frame
Start Date: 2013-08
Completion Date: 2017-08
Participants
Target number of participants: 30
Treatments
Blood collection and skin biopsies
Authors
John McGrath, Alain Hovnanian
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France

This content was sourced from clinicaltrials.gov