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Epidermolysis Bullosa clinical trials

View clinical trials related to Epidermolysis Bullosa.

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NCT ID: NCT01619670 Terminated - Wound Healing Clinical Trials

A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa

Start date: June 2012
Phase: Phase 4
Study type: Interventional

Epidermolysis Bullosa (EB) is a very rare disease, with a severe impact on the life of the patient and the caregiver. Epidermolysis Bullosa (EB) comprises a group of genetically determined skin fragility disorders characterized by blistering of the skin and mucosae following mild mechanical trauma. There is no specific proven treatment for any form of EB, and the mainstay of clinical management is based on protection and avoidance of provoking factors. Chronic nonhealing erosions and ulcers have been treated with conventional split-thickness skin grafts. Alternatively some patients may benefit from the use of autologous or allogeneic cultured keratinocyte grafts.

NCT ID: NCT01556308 Completed - Clinical trials for Epidermolysis Bullosa Simplex Dowling Meara

Study of Inflammatory Mechanisms in Epidermolysis Bullosa Simplex- Dowling Meara

Start date: March 2012
Phase: N/A
Study type: Interventional

Introduction: Epidermolysis Bullosa Simplex-Dowling-Meara (DM-EBS) is a rare genodermatosis characterized by spontaneous or post traumatic large cutaneous blisters. No curative treatment is actually available. Some data suggest a role of inflammation in the occurrence of blisters. The aim of this study is to study the epidermis inflammatory mechanisms in DM-EBS. Material and methods: A first retrospective immunohistochemical study will be led on remainder skin biopsies of DM-EBS patients took for the diagnosis. A second clinical multicentric prospective study will be led on 8 patients older than 1 year with severe DM-EBS. After informed written consent, they will answer to a standardized questionnaire. In case of flare of the disease, the liquid and the top of the blisters will be took. Samples will be analyzed in the Pr Nicolas 851 INSERM unit. After centrifugation of the liquid blisters, the repartition of inflammatory cells will be evaluated by Fluorescence Activated Cell Sorting on the pellet. Markers of inflammation will be evaluated on the surnageant with Luminex® technical with a multiplex targeting cytokines and chemokines. An immuno-histochemic analysis in association with a quantitative PCR will be made on the top of the blisters. If unknown, genotypic study will be made. Perspectives: A better comprehension of physiopathological mechanisms in DM-EBS could offer new therapeutic ways.

NCT ID: NCT01538862 Completed - Clinical trials for Dystrophic Epidermolysis Bullosa

Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa

Start date: February 2012
Phase: N/A
Study type: Interventional

This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is effective as a treatment of Dystrophic Epidermolysis Bullosa (EB.) Patients will receive one course of treatment with the study drug. The course will be 7 days in length. After receiving GCSF, patients will be followed at 7 and 30 days following the discontinuation of the drug. Thirty day follow up can be done via telephone communication with the patient or family.

NCT ID: NCT01528306 Withdrawn - Clinical trials for Dystrophic Epidermolysis Bullosa

A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

Start date: March 2012
Phase: Phase 2
Study type: Interventional

This is a pilot study designed to see if HP802-247, an investigational treatment with living human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis Bullosa (DEB). The durability of the skin in healed wounds treated with HP802-247 will also be assessed.

NCT ID: NCT01454687 Withdrawn - Clinical trials for Epidermolysis Bullosa

Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes

Start date: October 2011
Phase: N/A
Study type: Interventional

The term epidermolysis bullosa (EB) is used to describe a group of genetic skin diseases associated with skin weakness, blisters, and chronic wounds. "Revertant mosaicism" means that there are two genetically different populations of cells due to spontaneous mutations. Some EB patients have normal, non-fragile skin patches which may be areas of revertant mosaicism. In the revertant areas, the proteins function normally, like non-EB skin. In this study, we plan to culture cells from the revertant areas and graft them on to the wounded areas.

NCT ID: NCT01340235 Recruiting - Clinical trials for Epidermolysis Bullosa

Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin

Start date: June 2011
Phase: Phase 3
Study type: Interventional

Dowling Meara type of epidermolysis bullosa simplex (EBS-DM) is a rare genodermatosis due to keratin 5 and 14 mutation, characterized by skin fragility and spontaneous or post traumatic blisters. Neonatal period and infancy are critical since this autonomic dominant affection usually improves with age. Cyclins seem to be efficient in some cases of EBS but are prohibited in children younger than 8 years old. Erythromycin can be a good alternative in this population due to its antibacterial and anti-inflammatory potential. The aim of this study is the evaluation of the efficiency of oral erythromycin to decrease the number of cutaneous blisters in severe EBS-DM patients from 6 months to 8 years old after 3 months of treatment. Primary end point is the number of patients with decrease of blisters' number of at least 20% after 3 months of treatment by oral erythromycin. It is a preliminary study on 8 patients. Treatment is oral erythromycin twice a day during 3 months. Follow up for each patient is 5 months. The duration of the study is 1 year.

NCT ID: NCT01294241 Completed - Clinical trials for Inherited Epidermolysis Bullosa

Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study was to compare intra-individually the reepithelialization of skin lesion(s) in inherited Epidermolysis bullosa (either 1 wound ≥10 cm2 and ≤200 cm2 in size divided in 2 equal halves or 2 comparable wounds of ≥5 cm2 each) treated with Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only.

NCT ID: NCT01263379 Completed - Clinical trials for Epidermolysis Bullosa

Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa

Start date: October 5, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This trial will create a skin graft, which the investigators call "LEAES," using the patient's own skin cells that have been genetically engineered in the lab to express a missing protein called type VII collagen. The corrected cells will be transplanted back to the patient.

NCT ID: NCT01033552 Completed - Clinical trials for Epidermolysis Bullosa

Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs

Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, single institution, phase II study in patients with epidermolysis bullosa (EB). The underlying hypothesis is that the infusion of bone marrow or umbilical cord blood from a healthy unaffected donor will correct the collagen, laminin, integrin, or plakin deficiency and reduce the skin fragility characteristic of severe forms of EB. A secondary hypothesis is that mesenchymal stem cells from a healthy donor will enhance the safety and efficacy of the allogeneic hematopoietic stem cell transplant as well as serve as a source of renewable cells for the treatment of focal areas of residual blistering.

NCT ID: NCT01019148 Recruiting - Clinical trials for Epidermolysis Bullosa Dystrophica

Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

Start date: November 10, 2009
Phase:
Study type: Observational

Recessive dystrophic epidermolysis bullosa (RDEB) is a disease caused by genetic mutations in the gene for type VII collagen. Patients with RDEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening subjects with RDEB to evaluate characteristics of the subjects and their cells in order to develop new strategies of therapy and determine whether subjects could be candidates for treatment studies.