A Multicenter, Prospective, Randomized, Open-label, Intra-patient Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated with Generalized Epidermolysis Bullosa

Shire Regenerative Medicine, Inc.0 个研究点目标入组 25 人开始时间: 2012年9月26日最近更新: 2013年10月21日

适应症

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•1. Ability of subject (or subject?s legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent/assent and authorization to use protected health information in accordance with national and local patient regulations.
•2. Male and female subjects.
•3. Stable nutritional status.
•4. Subjects with a confirmed diagnosis of generalized Epidermolysis Bullosa and cutaneous wounds meeting the following criteria:
•a. Anatomical location: arms, legs, thorax, or back above the waistline and below the neck.
•b. Documented age (duration) of the wound(s).
•c. One or more wounds capable of potentially meeting the following wound selection criteria at the end of the observation period:
•i. Two clinically non-infected cutaneous wounds with no clinically meaningful change in wound size during the observation period.
•ii. Two matched wounds.
•5. Negative urine pregnancy test for women of child-bearing potential.
•6. Female subjects of childbearing potential and male subjects of procreative capacity must agree to use an effective method of contraception.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Pregnant or nursing women.
•2. Diagnosis of non-genetic generalized EB.
•3. Localized, active clinical infection of study wounds.
•4. Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures.
•5. Known allergy to bovine products.
•6. Known allergy to silver products.
•7. Systemic infection at the time of enrolment in the study.
•8. Taking, or have participated in other clinical studies involving gene therapy, stem cell therapy, recombinant DNA/protein therapy. If received, other investigational drug treatments for EB that have not met the acceptable washout periods of: 1 month for topical treatments, 3 months for prior ABH001 treatment on the study wound, 6 months for small molecules, and 1 year or five half-lives for biologics.
•9. History of malignant skin disease.

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