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

Primary Purpose

EPIDERMOLYSIS BULLOSA

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

CX501

Occlusive non adherent dressing

About this trial

This is an interventional treatment trial for EPIDERMOLYSIS BULLOSA

Eligibility Criteria

28 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fundación Mir-Mir
Hospital La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CX501

Non adherent dressing

Arm Description

Cultured chimeric skin

Occlusive non adherent dressing

Outcomes

Primary Outcome Measures

Time to epithelization

Secondary Outcome Measures

Fibroblast persistence

Incidence of Adverse Events

Full Information

NCT ID

NCT00987142

First Posted

September 29, 2009

Last Updated

July 30, 2019

Sponsor

Tigenix S.A.U.

1. Study Identification

Unique Protocol Identification Number

NCT00987142

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tigenix S.A.U.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

EPIDERMOLYSIS BULLOSA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CX501

Arm Type

Experimental

Arm Description

Cultured chimeric skin

Arm Title

Non adherent dressing

Arm Type

Active Comparator

Arm Description

Occlusive non adherent dressing

Intervention Type

Drug

Intervention Name(s)

CX501

Intervention Description

Cultured chimeric skin

Intervention Type

Device

Intervention Name(s)

Occlusive non adherent dressing

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to epithelization

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Fibroblast persistence

Time Frame

3, 8 and 12 months

Title

Incidence of Adverse Events

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Carlos López, MD

Organizational Affiliation

Hospital La Paz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fundación Mir-Mir

City

Barcelona

Country

Spain

Facility Name

Hospital La Paz

City

Madrid

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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