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

EPIDERMOLYSIS BULLOSA Clinical Trial

— TCEB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987142
• Other study ID #: CX501/TCEB
• Status: Completed
• Phase: Phase 2
• Start date: December 2006
• Est. completion date: May 2010

Study information

• Verified date: July 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• EPIDERMOLYSIS BULLOSA

Intervention

Drug:
• CX501
Cultured chimeric skin

Device:
• Occlusive non adherent dressing
Application of an occlusive non adherent dressing in the skin donor site

Locations

Country	Name	City	State
Spain	Fundación Mir-Mir	Barcelona
Spain	Hospital La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Tigenix S.A.U.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to epithelization		21 days
Secondary	Fibroblast persistence		3, 8 and 12 months
Secondary	Incidence of Adverse Events		12 months