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

This study has been completed.
Sponsor:
Information provided by:
Cellerix
ClinicalTrials.gov Identifier:
NCT00987142
First received: September 29, 2009
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
EPIDERMOLYSIS BULLOSA
 Drug: CX501
Device: Occlusive non adherent dressing
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Open-Label Multicentre Clinical Trial To Assess The Efficacy And Safety Of A New Therapy With Cultured Chimeric Skin For The Treatment Of Skin Lesions In Patients With Epidermolysis Bullosa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cellerix:

Primary Outcome Measures:
  • Time to epithelization [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fibroblast persistence [ Time Frame: 3, 8 and 12 months ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: December 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CX501
Cultured chimeric skin
 Drug: CX501
Cultured chimeric skin
Active Comparator: Non adherent dressing
Occlusive non adherent dressing
 Device: Occlusive non adherent dressing
Application of an occlusive non adherent dressing in the skin donor site

Detailed Description:

Reconstruction of interdigital commisures in patients with severe skin syndactyly using laminar grafts that will be uniformly and systematically taken with an electrical or compressed air dermatome on an aseptic area and with the same extent and depth in microns in all patients.

Immediately after the surgical procedure, a patch of cultured chimeric skin (experimental therapy) will be implanted in a half of the skin defect of the patient, and an occlusive non - adherent dressing (control) will be implanted in the other half.

Patients will initially be followed up every two days until epithelisation occurs (approximately 21 days after surgery) and at 3,8,and 12 months of follow-up.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients of both sexes over 28 days of age.
  • Patients with recessive dystrophic epidermolysis bullosa diagnosed by clinical and historical criteria with severe skin syndactyly in whom reconstructive surgery is indicated.
  • Patients whose legal guardians have given written informed consent for participation in the study before any study procedure is performed.
  • Patients aged ≥ 12 years who have given written informed consent for participation in the study before any study procedure is performed.

Exclusion criteria:

  • Women of childbearing age not using effective contraceptive methods (oral contraception)
  • Pregnant or nursing women
  • Documented or suspected hypersensitivity to any of the therapeutic agents included in the study, including anaesthetic drugs.
  • Patients with a history of malignant tumor in the past 5 years
  • Patients with a diagnosis of active tuberculosis at the time of recruitment
  • Patients with prior positive markers for any of the following pathogens: hepatitis b and c, hiv-1 and hiv-2
  • Patients with a history of clinically relevant hepatic, gastrointestinal, haematological, pulmonary, or neurological disease no directly related to epidermolysis bullosa.
  • Any other medical condition which, in the investigator´s judgment, might interfere with optimal participation in the study or involve a significant risk for the patient.
  • Alcoholism, drug addiction, psychiatric disorders, or other factors present in legal guardians which,in the investigator´s judgment may complicate patient participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987142

Locations
Spain
Fundación Mir-Mir
Barcelona, Spain
Hospital La Paz
Madrid, Spain
Sponsors and Collaborators
Cellerix
Investigators
Principal Investigator: Juan Carlos López, MD Hospital La Paz
  More Information

No publications provided

Responsible Party: Lydia Dorrego, Clinical Operations Director., CELLERIX
ClinicalTrials.gov Identifier: NCT00987142     History of Changes
Other Study ID Numbers: 2005-002329-30
Study First Received: September 29, 2009
Last Updated: June 13, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous

ClinicalTrials.gov processed this record on May 16, 2013