Phase 3 VIITAL Clinical Trial of EB-101
EB-101 is a gene-corrected cell therapy for the treatment of RDEB, a rare connective tissue disorder without an approved therapy. The EB-101 VIITAL™ study is a Phase 3 randomized clinical trial enrolling 10 to 15 RDEB patients with approximately 35 large, chronic wound sites treated in total.
Recessive Dystrophic Epidermolysis Bullosa, or 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. In this study, investigators will take two small biopsies of skin tissue, grow and multiply those cells, and then insert the correct type VII collagen gene. This may provide the cells with the ability to grow and develop normal skin. After cells’ gene transfer, the cells are further grown into a larger sheet that is then transplanted back onto the patient. After treatment, patients are followed for 26 weeks to assess safety and efficacy.
VIITAL™ Study Overview
VIITAL™ Study: Ensuring Participant Safety During COVID-19
For more information about enrolling in our clinical trials, contact us at EB@abeonatherapeutics.com.
Phase 1/2 Clinical Trial of EB-101
A single-center randomized clinical trial assessing EB-101 for wound healing in patients with RDEB. Data from a randomized clinical trial showed EB-101 treatment of large, chronic RDEB wounds is associated with durable healing for up to five years and pain relief.
Visit Clinical Trials.gov for more information.
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.
RDEB Community Member Lara Hernandez’s Perspectives on Living with EB and Her Clinical Trial Experience:VIITAL™ Study Overview and
Wound Care Tips with EBRP
VIITAL™ Investigator Dr. Jean Tang
Presents on EB-101 at PeDRA