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

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Brief Title

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

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

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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Time to epithelization

Secondary Outcome

 Fibroblast persistence

Condition

EPIDERMOLYSIS BULLOSA

Intervention

CX501

Study Arms / Comparison Groups

 CX501
Description:  Cultured chimeric skin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

December 2006

Completion Date

May 2010

Primary Completion Date

May 2010

Eligibility 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.
      

Gender

All

Ages

28 Days - N/A

Accepts Healthy Volunteers

No

Contacts

Juan Carlos López, MD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT00987142

Organization ID

CX501/TCEB


Responsible Party

Sponsor

Study Sponsor

Tigenix S.A.U.


Study Sponsor

Juan Carlos López, MD, Principal Investigator, Hospital La Paz


Verification Date

July 2019