A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2012

Primary Completion Date

March 31, 2013

Study Completion Date

July 31, 2013

Conditions
Dystrophic Epidermolysis Bullosa
Interventions
BIOLOGICAL

HP802-247

"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"

OTHER

Placebo

"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"

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Healthpoint

INDUSTRY