A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

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Brief Title

A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

Official Title

An Exploratory, Cross-Over Study of the Safety of HP802-247 Applied to Open Wounds of Subjects With Dystrophic Epidermolysis Bullosa

Brief Summary

      This is a pilot study designed to see if HP802-247, an investigational treatment with living
      human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis
      Bullosa (DEB). The durability of the skin in healed wounds treated with HP802-247 will also
      be assessed.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Time to healing

Secondary Outcome

 Wound pain as measured by faces pain scale

Condition

Dystrophic Epidermolysis Bullosa

Intervention

HP802-247

Study Arms / Comparison Groups

 HP802-247
Description:  

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

Biological

Estimated Enrollment

0

Start Date

March 2012

Completion Date

July 2013

Primary Completion Date

March 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Written consent must be obtained from a parent or legally authorized representative.
             Assent will be obtained according to local requirements.

          -  Subjects with a clinical diagnosis of DEB with recurring blisters, ≥ 2 years of age at
             Screening. Subjects may be of either sex and of any race or skin type provided that
             their skin color, in the opinion of the Investigator, will not interfere with the
             study assessments.

          -  A parent or legally authorized representative must be willing and able to ensure
             subject is present for all required study visits.

          -  A parent or legally authorized representative must be able to follow instructions.

          -  Have an open wound for ≤ 72 hours that:

               -  is still open and has not scabbed or crusted over

               -  has no dermatologic disease and/or condition in the treatment area (other than
                  DEB with recurring blisters), including active or recent infection (within 7
                  days) that may be exacerbated by treatment, require treatment with antibiotics /
                  antifungals /antivirals, require a surgical intervention, or cause difficulty
                  with examination

               -  is ≥ 4 cm² and ≤ 48 cm2 in total area (open portion)

          -  Females of childbearing potential (defined as post-menarcheal as documented in the
             medical history) may participate in the study if they meet all of the following
             conditions:

               -  they are not breast feeding;

               -  they have a negative urine pregnancy test at Week 1 Period 1;

               -  they agree to undertake scheduled urine pregnancy tests at Week 1 for Periods 1,
                  2, & 3 and at study exit

               -  they do not intend to become pregnant during the study;

               -  they are using adequate birth control methods and they agree to continue using
                  those methods for the duration of the study

          -  A parent or legally authorized representative must be willing and able to ensure
             subject is present for all required study visits (for minor subjects)

          -  A parent or legally authorized representative must be able to follow instructions (for
             minor subjects)

        Exclusion Criteria:

          -  Contraindications or hypersensitivity to the use of the test article, their components
             (e.g., aprotinin, fibrinogen), or substances used in the manufacture of the test
             article (e.g., penicillin, streptomycin, amphotericin B, bovine serum albumin).

          -  Therapy with another investigational agent within thirty (30) days of the Screening
             Visit, or during the study.

          -  Have uncontrolled intercurrent or chronic illness that, in the opinion of the
             Investigator, would limit compliance with study requirements, represents a potential
             safety risk, or require treatment with an excluded drug/treatment.

          -  The Investigator or Medical Monitor may declare any subject ineligible for a valid
             medical reason.
      

Gender

All

Ages

2 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Herbert B Slade, MD, , 



Administrative Informations


NCT ID

NCT01528306

Organization ID

802-247-09-026


Responsible Party

Sponsor

Study Sponsor

Healthpoint


Study Sponsor

Herbert B Slade, MD, Study Chair, Healthpoint


Verification Date

May 2012