- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00587223
Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)
June 25, 2010 updated by: Organogenesis
A Prospective, Multicenter, Within Subject Controlled Study to Evaluate the Effect of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305-5168
- Stanford University School of Medicine
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Florida
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Miami, Florida, United States, 33125
- University of Miami - Miller School of Medicine
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45229
- Children's Hospital of Cincinnati
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Texas
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Houston, Texas, United States, 77030-1341
- University of Texas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is between 2 and 65 years of age.
- Subject with clinical and histological diagnosis of junctional or dystrophic EB with documented electron microscopy or immunofluorescence microscopy.
- Subject has at least two non-adjacent EB lesions, at least 4 cm apart. The two selected EB lesions must be relatively matched in terms of diagnosis, location, level of erosion and size. Lesions may be on the same limb.
- Subject with dystrophic or junctional EB lesions between 10-44 cm2 present for at least 6 weeks. For the purposes of this study, a lesion is defined as a wound resulting from a post blister erosion.
- Subject who is a female of child-bearing potential (females >10 years of age) must have a documented negative urine or serum pregnancy test. Sexually active females must be practicing a medically proven form of contraception during the course of the study period.
- Subject or legal guardian must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form or Assent Form.
- Subject and/or legal guardian must be able and willing to follow study procedures and instructions.
Exclusion Criteria:
- Subject with lesions only on the soles, posterior thigh or gluteus maximus.
- Subject whose lesion has healed 20% or greater in area from post debridement (if applicable) Baseline Screen (Visit 1) to post debridement Day 0 (Visit 2) as determined by wound tracings.
- Subject with uncontrolled diabetes mellitus (glycosylated HbA1C > 10%), cancer (biopsy confirmed active malignancy), or positive HIV test.
- Subject is a child (<18 years of age) who is currently receiving or has received oral steroid therapy exceeding a total daily dose of 0.5mg/kg for more than two weeks, radiation or other immuno-suppressive therapy which would interfere with wound healing within the past four weeks.
- Subject is an adult (>18 years of age) who is currently receiving or has received chronic high dose steroid therapy exceeding a total daily dose of 20mg for more than two weeks, radiation or other immuno-suppressive therapy which would interfere with wound healing within the past four weeks.
- Subject who is currently on or has received topical steroidal therapy within 30 days before screening. Inhaled steroids are allowed.
- Subject with the presence of acute infections in the areas intended for treatment.
- Subject with a history of squamous cell carcinoma.
- Known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
- Subject who is lactating or pregnant (hCG positive as determined by lab testing).
- Subject is a child (<18 years of age) with liver (ALT/SGPT, ALP, AST/SGOT, bilirubin, total protein, LDH) and/or renal function (BUN and creatinine) tests > 2 x upper limit of normal (ULN). Albumin < 2.0 mg/dL.
- Subject is an adult (>18 years of age) with liver (ALT/SGPT, ALP, AST/SGOT, bilirubin, total protein, LDH) and/or renal function (BUN and creatinine) tests > 2 x upper limit of normal (ULN). Albumin < 2.0 mg/dL.
- Subject enrolled in any wound or investigational device study for any disease within the past four weeks.
- Subject who has received an investigational drug or biological treatment within three months.
- Subject previously treated with Apligraf, Dermagraft or any other cell therapy at the target sites.
- Subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes.
- Subject who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Apligraf (a living bilayered cell therapy product)
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Up to 3 applications: Day 0, Month 1, Month 2.
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Active Comparator: 2
Dressing regimen comprised of a primary nonadherent dressing, nonstick gauze and standard dressing retainer.
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Dressing regimen will be comprised of a primary nonadherent dressing, nonstick gauze and standard dressing retainer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of Wounds First Achieving 100% Epithelialization of Tissue With the Absence of Drainage (i.e. Complete Wound Closure) Through Study Week 12
Time Frame: Through 12 weeks
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Through 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time Until Complete Closure
Time Frame: through 12 weeks
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through 12 weeks
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Rate of Complete Wound Closure Over Time
Time Frame: through 12 weeks
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through 12 weeks
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Recurrence of Epidermolysis Bullosa (EB) Lesions
Time Frame: through 12 months
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through 12 months
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Reduction of Intensity of Pain
Time Frame: through 12 weeks
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through 12 weeks
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Proportion of Wounds Experiencing an Adverse Event
Time Frame: through 12 months
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through 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Damien Bates, MD, PhD, FRACS (Plast.), Organogenesis Inc.
- Principal Investigator: Elizabeth Alvarez- Connelly, MD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
January 7, 2008
Study Record Updates
Last Update Posted (Estimate)
June 29, 2010
Last Update Submitted That Met QC Criteria
June 25, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-EB-001-AG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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