Viewing Study NCT01874769



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Last Modification Date: 2024-10-26 @ 11:08 AM
Study NCT ID: NCT01874769
Status: UNKNOWN
Last Update Posted: 2013-12-18
First Post: 2013-04-03

Brief Title: Study of Immune Tolerance and Capacity for Wound Healing of Patients With Recessive Dystrophic Epidermolysis Bullosa RDEB
Sponsor: Institut National de la Santé Et de la Recherche Médicale France
Organization: Institut National de la Santé Et de la Recherche Médicale France

Study Overview

Official Title: Study of Immune Tolerance and Capacity for Wound Healing of Patients With Recessive Dystrophic Epidermolysis Bullosa RDEB
Status: UNKNOWN
Status Verified Date: 2013-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RDEB
Brief 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
Detailed Description: In the perspective of future therapeutic interventions which could involve protein cellular andor gene therapy it is essential to investigate RDEB patients with regards to their immune tolerance to type VII collagen and their capacity of their cells for tissue reconstruction

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2012-A01051-42 REGISTRY IDRCB None