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Clinical Trial Summary

Recessive dystrophic epidermolysis bullosa (RDEB) is a hereditary skin disease characterized by cutaneous and mucosa fragility. Blister formations and erosions, resulting in chronic wounds and dystrophic scars, lead development of aggressive cutaneous squamous cell carcinoma (cSCC) in young subjects. cSCC in RDEB patients are often recurrent and sometimes aggressive. Although fibrotic and inflammatory microenvironment plays an important role in the tumoral process, specific mechanisms in cSCC of RDEB patients are still unknown. Actually, the only treatment is a wide surgical excision with poor prognostic (80% of death after the first occurrence of cSCC).

The objective of the study is to describe the molecular signatures in the cSCC in RDEB patients


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04285294
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact Emmanuel BOURRAT, Dr
Phone +33 1 42 49 90 90
Email emmanuelle.bourrat@aphp.fr
Status Not yet recruiting
Phase
Start date March 2020
Completion date December 2023

See also
  Status Clinical Trial Phase
Completed NCT02493816 - Safety Study of Gene-modified Autologous Fibroblasts in Recessive Dystrophic Epidermolysis Bullosa Phase 1
Completed NCT04599881 - A Study of PTR-01 in Recessive Dystrophic Epidermolysis Bullosa Phase 2
Completed NCT04520022 - Safety and Effectiveness Study of Allogeneic Umbilical Cord Blood-derived Mesenchymal Stem Cell in Patients With RDEB Phase 1/Phase 2
Not yet recruiting NCT03632265 - Study of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa Phase 3
Recruiting NCT05944250 - A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients N/A
Recruiting NCT04917887 - Long-Term Follow-up Protocol
Completed NCT04917874 - A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa Phase 3
Active, not recruiting NCT04213261 - A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa Phase 3
Active, not recruiting NCT02323789 - Mesenchymal Stromal Cells in Adults With Recessive Dystrophic Epidermolysis Bullosa Phase 1/Phase 2
Recruiting NCT01874769 - Study of Immune Tolerance and Capacity for Wound Healing of Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB) N/A
Recruiting NCT03392909 - Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Phase 1/Phase 2
Completed NCT03752905 - A Phase 1/2 Trial of PTR-01 in Adult Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB) Phase 1/Phase 2
Terminated NCT02984085 - Clinical Trial to Assess Safety and Efficacy of Autologous Cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified in Patients With RDEB. Phase 1/Phase 2
Completed NCT04227106 - Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) Phase 3
Completed NCT02698735 - Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Nonsense Mutation Patients Phase 1/Phase 2
Completed NCT03012191 - Gentamicin for RDEB Phase 1/Phase 2
Completed NCT03529877 - Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa Phase 1/Phase 2
Completed NCT05143190 - Extension Study to PTR-01-002 (A Study in Recessive Dystrophic Epidermolysis Bullosa (RDEB) Patients Previously Treated With PTR-01) Phase 2
Recruiting NCT04177498 - Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC Early Phase 1
Completed NCT04491604 - Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB Phase 3