A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa

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Brief Title

A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa

Official Title

A Prospective Single Center Within Subject Controlled Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa

Brief Summary

      Epidermolysis Bullosa (EB) is a very rare disease, with a severe impact on the life of the
      patient and the caregiver. Epidermolysis Bullosa (EB) comprises a group of genetically
      determined skin fragility disorders characterized by blistering of the skin and mucosae
      following mild mechanical trauma. There is no specific proven treatment for any form of EB,
      and the mainstay of clinical management is based on protection and avoidance of provoking
      factors. Chronic nonhealing erosions and ulcers have been treated with conventional
      split-thickness skin grafts. Alternatively some patients may benefit from the use of
      autologous or allogeneic cultured keratinocyte grafts.
    

Detailed Description

      Apligraf is a living bilayered cell therapy product. Apligraf is constructed of Type I bovine
      collagen. The mechanism of action of Apligraf is still unknown. No clinical evidence of
      rejection of Apligraf was observed when placed on acute or chronic wounds. Apligraf has been
      suggested to act as a "smart" material for wound healing by interacting with the surrounding
      environment to promote healing. It provides components with multiple actions, interacts with
      wounds in biological and physical ways, and appears to adapt to the wound environment and
      probably produces numerous pro-healing cytokines. The purpose of this study is to evaluate
      the use of Apligraf for the treatment of nonhealing wounds in subjects with epidermolysis
      bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional
      nonadherent dressing. The study is a pivotal, single center, within subject controlled
      observational trial in which the rate of wound healing, recurrence of EB lesions, subject
      report of pain will be compared to wounds treated with Control treatment. Subjects between 2
      and 65 years of age, inclusive, with epidermolysis bullosa lesions will be screened for this
      study. For each subject at least two designated treatment sites will be selected. In case of
      two comparable treatment sites the most right side will receive Apligraf and the most left
      side will receive control. Efficacy will be assessed by clinical observations, wound tracings
      and photographs.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Proportion of wounds

Secondary Outcome

 Time

Condition

Epidermolysis Bullosa

Intervention

Apligraf

Study Arms / Comparison Groups

 no intervention
Description:  standard wound care

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

3

Start Date

June 2012

Completion Date

January 2015

Primary Completion Date

January 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Subject is between 2 and 65 years of age.

          2. Subject with clinical confirmed diagnosis of EB.

          3. Subject has at least two lesions, if in a situation with two non-adjacent EB lesions,
             at least 4 cm apart.

          4. Subject with EB lesions at least 2 cm2 present for at least 3weeks. For the purposes
             of this study, a lesion is defined as a wound resulting from a post blister erosion.

          5. 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.

          6. Subject or legal guardian must have read, understood and signed an institutional
             review board (IRB) approved Informed Consent Form or Assent Form.

          7. Subject and/or legal guardian must be able and willing to follow study procedures and
             instructions.

             -

        Exclusion Criteria:

          -  1. 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.

             2. Subject with uncontrolled diabetes mellitus (glycosylated HbA1C > 10%), cancer
             (biopsy confirmed active malignancy), or positive HIV test.

             3. 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.

             4. 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.

             5. Subject who is currently on or has received topical steroidal therapy within 30
             days before screening. Inhaled steroids are allowed.

             6. Subject with the presence of acute infections in the areas intended for treatment.

             7. Known hypersensitivity to bovine collagen or to the components of the Apligraf
             agarose shipping medium.

             8. Subject who is lactating or pregnant (hCG positive as determined by lab testing).

             9. Subject enrolled in any wound or investigational device study for any disease
             within the past four weeks.

             10. Subject who has received an investigational drug or biological treatment within
             three months.

             11. 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.

             12. 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.
      

Gender

All

Ages

2 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Andreas Arnold, MD, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT01619670

Organization ID

EKBB 235/11


Responsible Party

Sponsor

Study Sponsor

University Hospital, Basel, Switzerland

Collaborators

 Organogenesis

Study Sponsor

Andreas Arnold, MD, Principal Investigator, University Hospital Basel, Dep. Dermatology and Venereology, Basel/Switzerland


Verification Date

March 2015