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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00987142
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : August 1, 2019
Information provided by (Responsible Party):
Takeda ( Tigenix S.A.U. )

Brief 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.

Condition or disease Intervention/treatment Phase
EPIDERMOLYSIS BULLOSA Drug: CX501 Device: Occlusive non adherent dressing Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time to epithelization [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Fibroblast persistence [ Time Frame: 3, 8 and 12 months ]
  2. Incidence of Adverse Events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00987142

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Fundación Mir-Mir
Barcelona, Spain
Hospital La Paz
Madrid, Spain
Sponsors and Collaborators
Tigenix S.A.U.
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Principal Investigator: Juan Carlos López, MD Hospital La Paz
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Responsible Party: Tigenix S.A.U. Identifier: NCT00987142    
Other Study ID Numbers: CX501/TCEB
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous