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Sponsored by: |
Organogenesis |
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Information provided by: | Organogenesis |
ClinicalTrials.gov Identifier: | NCT00587223 |
The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional nonadherent dressing. A matched-pair design will be used to evaluate Apligraf treatment versus conventional treatment in 68 study pairs.
Condition | Intervention | Phase |
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Epidermolysis Bullosa, Junctional Epidermolysis Bullosa Dystrophica |
Device: Apligraf Other: Standard dressing regimen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multicenter, Within Subject Controlled Study to Evaluate the Effect of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa |
Estimated Enrollment: | 68 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Apligraf (a living bilayered cell therapy product)
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Device: Apligraf
Up to 3 applications: Day 0, Month 1, Month 2.
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2: Active Comparator
Dressing regimen comprised of a primary nonadherent dressing, nonstick gauze and standard dressing retainer.
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Other: Standard dressing regimen
Dressing regimen will be comprised of a primary nonadherent dressing, nonstick gauze and standard dressing retainer
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Ages Eligible for Study: | 2 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michelle Vieira DiSalvo | 781-401-1119 | mdisalvo@organo.com |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305-5168 | |
Contact: Emily Gorell 650-725-4302 egorell@stanford.edu | |
Principal Investigator: Anna L Bruckner, MD | |
United States, Florida | |
University of Miami - Miller School of Medicine | Recruiting |
Miami, Florida, United States, 33125 | |
Contact: Carol Kittles 305-243-8485 ckittles@med.miami.edu | |
Principal Investigator: Elizabeth Alvarez-Connelly, MD | |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Carol Coppola, RN 212-305-6953 Cc2241@columbia.edu | |
Principal Investigator: Kimberly Morel, MD | |
United States, Ohio | |
Children's Hospital of Cincinnati | Not yet recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Gerry Kelly 513-636-7931 geraldine.kelly-mancuso@cchmc.org | |
Principal Investigator: Anne W Lucky, MD | |
United States, Texas | |
University of Texas | Recruiting |
Houston, Texas, United States, 77030-1341 | |
Contact: Maria Lopez 713-500-8266 Maria.D.Lopez@uth.tmc.edu | |
Principal Investigator: Adelaide Hebert, MD |
Principal Investigator: | Elizabeth Alvarez- Connelly, MD | University of Miami, Miller School of Medicine |
Study Director: | Damien Bates, MD, PhD, FRACS (Plast.) | Organogenesis Inc. |
Responsible Party: | Organogenesis Inc. ( Katherine B. Giovino, Director of Clinical Operations ) |
Study ID Numbers: | 06-EB-001-AG |
Study First Received: | December 21, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00587223 |
Health Authority: | United States: Food and Drug Administration |
Skin Diseases Skin Diseases, Vesiculobullous Collagen Diseases Epidermolysis Bullosa, Junctional Skin Abnormalities Epidermolysis Bullosa Dystrophic epidermolysis bullosa |
Epidermolysis bullosa, junctional Epidermolysis bullosa Genetic Diseases, Inborn Connective Tissue Diseases Epidermolysis Bullosa Dystrophica Congenital Abnormalities Skin Diseases, Genetic |