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Epidermolysis Bullosa clinical trials

View clinical trials related to Epidermolysis Bullosa.

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NCT ID: NCT04213703 Recruiting - Clinical trials for Epidermolysis Bullosa

A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa

Start date: March 2, 2020
Phase:
Study type: Observational

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

NCT ID: NCT04213261 Active, not recruiting - Clinical trials for Recessive Dystrophic Epidermolysis Bullosa

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

DEFI-RDEB
Start date: June 9, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether administration of FCX-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Recessive Dystrophic Epidermolysis Bullosa. Funding Source - FDA OOPD

NCT ID: NCT04186650 Active, not recruiting - Clinical trials for Epidermolysis Bullosa Dystrophica, Recessive

Ex Vivo Gene Therapy Clinical Trial for RDEB Using Genetically Corrected Autologous Skin Equivalent Grafts

EBGraft
Start date: January 10, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II clinical trial aims to treat 3 adult subjects with Recessive Dystrophic Epidermolysis Bullosa, expressing residual C7 levels, by genetically corrected autologous skin equivalent grafts on selected areas (up to 300 cm2).

NCT ID: NCT04177498 Recruiting - Clinical trials for Recessive Dystrophic Epidermolysis Bullosa

Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC

Start date: August 24, 2021
Phase: Early Phase 1
Study type: Interventional

This pilot trial studies how rigsertib sodium works in treating patients with Recessive Dystrophic Epidermolysis bullosa (RDEB) with locally advanced Squamous Cell Carcinoma (SCC). Rigosertib may selectively target Epidermolysis bullosa (EB) cancer cells while leaving normal EB cells unaffected.

NCT ID: NCT04173650 Not yet recruiting - Clinical trials for Dystrophic Epidermolysis Bullosa

MSC EVs in Dystrophic Epidermolysis Bullosa

Start date: April 2024
Phase: Phase 1/Phase 2
Study type: Interventional

INVESTIGATIONAL PRODUCT: AGLE-102 is an allogeneic derived extracellular vesicle (EV) product derived from normal donor mesenchymal stem cells (MSCs). INDICATION AND RATIONALE: The aim of the study is to assess the safety and efficacy of AGLE-102 in the treatment of lesions in subjects with Epidermolysis Bullosa (EB). STUDY DESIGN: This is a phase 1/2A, non randomized, multi-center, ascending dose, study to assess the effectiveness and safety of AGLE-102 on lesions in subjects with EB.

NCT ID: NCT04171661 Active, not recruiting - Clinical trials for Epidermolysis Bullosa Dystrophica

Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa

SASS
Start date: December 10, 2019
Phase: Early Phase 1
Study type: Interventional

Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.

NCT ID: NCT04153630 Active, not recruiting - Clinical trials for Epidermolysis Bullosa Dystrophica, Recessive

Safety Study and Preliminary Efficacy of Infusion Haploidentical Mesenchymal Stem Cells Derived From Bone Marrow for Treating Recessive Dystrophic Epidermolysis Bullosa

Start date: May 17, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I / II pilot clinical trial, to evaluate the safety and preliminary efficacy of the systemic infusion of mesenchymal stem cells derived from bone marrow (BM-MSCs) from a haploidentical donor to improve the healing process and / or the mucocutaneous fragility phenotype associated with EBDR.

NCT ID: NCT04140786 Recruiting - Clinical trials for Junctional Epidermolysis Bullosa

Optimizing IV Gentamicin in JEB

Start date: October 31, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Herlitz junctional epidermolysis bullosa (H-JEB), an incurable and fatal inherited skin disease, is caused by loss-of-function mutations in LAMA3, LAMB3 and LAMC2. These mutations result in diminished laminin 332 and epidermal-dermal adherence. 85% of JEB patients have nonsense mutations in LAMA3, LAMB3, or LAMC2, suggesting that H-JEB is a prime therapeutic target for nonsense suppression therapy. The investigators recently demonstrated in three patients that topical gentamicin created new and stable laminin 332 at the dermal-epidermal junction (DEJ), and also improved wound closure and skin quality. Furthermore, these preliminary studies showed that intravenous gentamicin also induced laminin 332 and transiently improved patients' clinical outcomes. No untoward side effects occurred. The investigators propose to optimize the intravenous gentamicin regimen including dosage and infusion schedules to enhance the therapeutic outcome. The milestones will be an increase of laminin 332 in the patients' DEJ, improvement in EB Disease Activity Scores, and no gentamicin-associated side effects.

NCT ID: NCT03942250 Completed - Clinical trials for Epidermolysis Bullosa

Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients

Start date: January 2017
Phase: N/A
Study type: Interventional

To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.

NCT ID: NCT03928093 Completed - Pain, Neuropathic Clinical Trials

Pregabalin Treatment for RDEB Pain and Itch

Start date: August 7, 2019
Phase: Phase 3
Study type: Interventional

Recessive dystrophic epidermolysis bullosa (RDEB) patients' quality of life is severely affected by neuropathic pain and itch, which have recently been demonstrated to be secondary to skin small fiber neuropathy. To date, there is no evidence on what the best agent is to control these symptoms. Based on the anecdotal data and safety profile, the investigators believe that pregabalin is a therapeutic agent that will be effective and safe in this population. The investigators propose to conduct a blinded study, using pregabalin versus placebo in which each patient serves as its own control (cross-over design). This is a feasibility study that will provide preliminary data on efficacy and safety of pregabalin in RDEB patients with neuropathic pain and itch and gather much needed data (dosage, titration schedule, outcome measures, etc) to inform the design of a larger cohort, controlled, multicenter trial.