NCT01528306

A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dystrophic Epidermolysis Bullosa

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2012-02-08
• Last updated: 2012-05-16