Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)

PHASE3TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Epidermolysis Bullosa, JunctionalEpidermolysis Bullosa Dystrophica
Interventions
DEVICE

Apligraf

Up to 3 applications: Day 0, Month 1, Month 2.

OTHER

Standard dressing regimen

Dressing regimen will be comprised of a primary nonadherent dressing, nonstick gauze and standard dressing retainer

Trial Locations (5)

10032

Columbia University Medical Center, New York

33125

University of Miami - Miller School of Medicine, Miami

45229

Children's Hospital of Cincinnati, Cincinnati

94305-5168

Stanford University School of Medicine, Stanford

77030-1341

University of Texas, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Organogenesis

INDUSTRY

NCT00587223 - Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB) | Biotech Hunter | Biotech Hunter