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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00987142
• Date of registration: 29/09/2009
• Prospective Registration: No
• Primary sponsor: Tigenix S.A.U.
• Public title: Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa TCEB
• Scientific 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
• Date of first enrolment: December 2006
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00987142
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Spain

Contacts

• Name: Juan Carlos López, MD
• Affiliation: Hospital La Paz

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

EPIDERMOLYSIS BULLOSA

Intervention(s)

Device: Occlusive non adherent dressing

Drug: CX501

Primary Outcome(s)

Time to epithelization [Time Frame: 21 days]

Secondary Outcome(s)

Incidence of Adverse Events [Time Frame: 12 months]

Fibroblast persistence [Time Frame: 3, 8 and 12 months]

Secondary ID(s)

CX501/TCEB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors