Trial ID or NCT#

NCT03632265

Status

not recruiting iconNOT RECRUITING

Purpose

VITAL is an open-label, Phase 3 study of one-time surgical application of at least 35 EB-101 grafts for the treatment of eligible, chronic open wound sites in up to 15 RDEB patients. Patient wounds will be randomized to receive grafting or remain untreated (control). Up to 6 wound sites for EB 101 grafting and at least 1 untreated control wound site will be performed for each patient.

Official Title

VITAL: A Pivotal Phase 3 Study of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) (GENE TRANSFER)

Eligibility Criteria

Ages Eligible for Study: Older than 6 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Jean Y. Tang MD PhD
Jean Y. Tang MD PhD
General dermatologist, Dermatologic oncologist, Cutaneous oncology specialist
Professor of Dermatology at the Stanford University Medical Center

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CONTACT

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