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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Wounds up to 12 cm2: 1 spray each component (0.5 x 106 cells per mL allogeneic human keratinocytes and fibroblasts) applied weekly as a topical spray for up to 4 weeks in each of 2 treatment periods Larger wounds: (\>12 cm2 and ≤ 24 cm2) 2 sprays each; (\>24 cm2 and ≤ 36 cm2) 3 sprays each; (\>36 cm2 and ≤ 48 cm2) 4 sprays each
Wounds up to 12 cm2: 1 spray each component (thrombin solution and fibrinogen solution) applied weekly as a topical spray for up to 4 weeks in each of 2 treatment periods Larger wounds: (\>12 cm2 and ≤ 24 cm2) 2 sprays each; (\>24 cm2 and ≤ 36 cm2) 3 sprays each; (\>36 cm2 and ≤ 48 cm2) 4 sprays each
Time to healing
Time to healing, defined as the number of days between wound onset (caregiver reported) and complete epithelialization (Investigator assessed).
Time frame: 4 weeks
Wound pain as measured by faces pain scale
Change from baseline (i.e., Week 1 of each period) in wound pain for each visit (Weeks 2-5 of each treatment period)as assessed by the Faces Pain Scale (FPS)
Time frame: 4 weeks for each of 3 treatment periods
Percent of change in wound area
Percent of change from baseline (i.e., Week 1 of each period) in the target wound area for each visit and Weeks 2-5 of each treatment period.
Time frame: 4 weeks for each of 3 treatment periods
Persistence of healing
Persistence of healing as assessed by lack of blister/wound recurrence for healed wounds of each period (up to 40 weeks following enrollment)
Time frame: 4 weeks for each of 3 treatment periods
Burning and stinging upon application
Burning and stinging upon application of HP802-247 or its Vehicle will be assessed at each visit of each period with the exception of the end of treatment visit (Weeks 1-4 of treatment period). Burning/stinging scale is a four point scale (i.e., none, mild, moderate, severe).
Time frame: 4 weeks for each of 3 treatment periods
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