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A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

NCT01528306 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-05-16

No results posted yet for this study

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

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 & Collaborators

  • Healthpoint

    lead INDUSTRY

Principal Investigators

  • Herbert B Slade, MD · Healthpoint

  • Jaime E Dickerson, PhD · Healthpoint

  • Herbert B Slade, MD · Healthpoint

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-03-31
Completion
2013-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528306 on ClinicalTrials.gov