Phase II clinical trial evaluating the safety and efficacy of a tissue engineered autologous skin substitute reconstructive surgery for basal cell carcinoma. - NanoGSkin/CB/2019

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud0 sites15 target enrollmentJuly 3, 2024

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud
Enrollment: 15
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

July 3, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

•Patients that give their informed consent for study participation., Adult (18 years of age or older), of any sex and racial origin., Clinical and dermatoscopic diagnosis of basal cell carcinoma with lesions on the scalp, torso or extremities, within a certain size that do not allow for surgical closure by direct suture or flaps., Namely, indication for Mohs surgery., Women with childbearing age or men capable of producing a child, should commit to use contraceptives of medically proven efficacy.

•Locally advanced basal cell carcinoma with evidence of deep tissue infiltration (fascia, muscle…)., Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow\-up., Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies., Lesions in the face., except for frontal\-lateral area and the temple., Injuries requiring urgent surgical intervention., Infected, necrotic, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft., Injuries that have received treatment with radiotherapy., Contraindication for Mohs surgery., Known allergies to antibiotics that could be part of the impurities in the PHA manufacturing process (gentamicin and amphotericin B)., Pregnant or breastfeeding women., Coagulation disorders that make the healing process of the injury difficult.