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 26 人开始时间: 2012年11月1日最近更新: 2013年10月28日

适应症

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•1. Subject or legal guardian must have read, understood and signed an Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent or Assent Form and must be able to and willing to follow study procedures and instructions.
•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 wound
•selection criteria at the end of the observation period:
•i. Clinically non-infected cutaneous wounds with no clinically meaningful change in wound size during the observation period.
•ii. Matched wounds/wound areas.
•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: 21
•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. Currently receiving or have received oral steroid therapy exceeding a total daily dose of 0.5 mg/kg (hydrocortisone equivalent potency) for more than 2 weeks, radiation or other immune-suppressive therapy within the previous 4 weeks.
•9. Participating or having participated in other investigational clinical studies, involving gene therapy, stem cell therapy and/or recombinant DNA/protein therapy.
•10. Received ABH001, or other biologic or cell therapy for the treatment of EB in the study wound sites within the previous 3 months
•11. Documented or suspected hypersensitivity to any of the therapeutic agents, including anaesthetic drugs.
•12. History of malignant skin disease.

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