Trials
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, an engineered cell therapy for the treatment of RDEB. Large chronic wounds treated in VIITAL™ measured greater than 20 cm2 of surface area and had remained open for more than six months.
The VIITAL™ study met its two co-primary efficacy endpoints demonstrating statistically significant, clinically meaningful improvements in wound healing and pain reduction in large chronic RDEB wounds. EB-101 was shown to be well-tolerated with no serious treatment-related adverse events observed, consistent with past clinical experience.
Visit Clinical Trials.gov for more information.
Status
Enrollment Closed
Study Sites
Stanford University School of Medicine
Palo Alto, California
United States
Irene Bailey: baileyhi@stanford.edu
University of Massachusetts Medical School
Worcester, Massachusetts
United States
Dr. Karen Wiss: DermResearch@umassmed.edu
Phase 1/2a Clinical Trial of EB-101
In a randomized phase 1/2a study conducted at Stanford University, EB-101 was well-tolerated and showed evidence of multi-year wound healing and pain reduction after treatment with a mean follow-up of 5.9 years and a maximum of eight years.
Visit Clinical Trials.gov for more information.
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.