Phase 3 VIITAL Clinical Trial of EB-101
Recessive dystrophic epidermolysis bullosa, or RDEB, is a rare connective tissue disorder without an approved therapy. RDEB is caused by a defect in the COL7A1 gene, resulting in the inability to produce Type VII collagen, which plays an important role in anchoring the dermal and epidermal layers of the skin. Characteristics of RDEB include severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. Large chronic wounds typically do not heal spontaneously and inflict the greatest pain and clinical burden on RDEB patients.
The VIITAL™ study is a Phase 3 randomized clinical trial investigating EB-101, a gene-corrected cell therapy for the treatment of RDEB, in a minimum of 10 patients with a minimum of 36 large, chronic wound sites treated in total. Large chronic wounds treated in VIITAL™ measured greater than 20 cm2 of surface area and had remained open for more than six months.
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Phase 1/2 Clinical Trial of EB-101
Who is eligible to participate in the VIITAL™ study?
Key criteria for eligible patients include the following, but a full list of inclusion and exclusion criteria are available here.
- Diagnosis of RDEB
- Age 6 years or older
- Positive expression of type VII collagen protein in the skin
- Two RDEB type VII collagen mutations
- ≥40 cm2 of chronically wounded areas on the trunk and/or extremities deemed suitable by the investigator for EB-101 treatment
- ≥2 matched eligible wound sites ≥20 cm2; present for ≥6 months, and stage 2 wound
The safety and efficacy of the investigational use of this product has not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.