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Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa

NCT00987142 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-08-01

No results posted yet for this study

Summary

A phase II, comparative, open label, prospective, multicentre clinical trial where each patient will undergo two procedures; implant of a patch of cultured chimeric skin (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing (control) in the other half for 12 months of follow-up in two Spanish centres.

Conditions

  • EPIDERMOLYSIS BULLOSA

Interventions

DRUG

CX501

Cultured chimeric skin

DEVICE

Occlusive non adherent dressing

Application of an occlusive non adherent dressing in the skin donor site

Sponsors & Collaborators

  • Tigenix S.A.U.

    lead INDUSTRY

Principal Investigators

  • Juan Carlos López, MD · Hospital La Paz

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Spain

Study Locations

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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 NCT00987142 on ClinicalTrials.gov