AUTologous skin-derived adult keratinocytes expanded; autologous skin-derived adult fibroblasts expanded for Basal cell carcinoma

Inclusion criteria

• {"criterion_text":"- Patients that give their informed consent for study participation."}
• {"criterion_text":"- Adult (18 years of age or older), of any sex and racial origin."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Namely, indication for Mohs surgery."}
• {"criterion_text":"- Women with childbearing age or men capable of producing a child, should commit to use contraceptives of medically proven efficacy."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Safety: adverse events and adverse reactions, including complications and sequelae in the healing of the surgical injury, making a distinction between early sequelae (hematoma, infection, blistering and graft loss) and late sequelae (necrosis, inflammation, granulation, abnormal healing, retractions, residual ulcers, pigmentation disorders...). Safety variables will be measured both in the surgical lesion and in the donor area, when applicable.","definition_or_measurement_approach":"Incidence of adverse events and adverse reactions related to the investigational products during implantation and follow-up; measured in the surgical lesion and donor area where applicable, distinguishing early and late sequelae (hematoma, infection, blistering, graft loss, necrosis, inflammation, granulation, abnormal healing, retractions, residual ulcers, pigmentation disorders)."}
• {"endpoint_text":"- Feasibility: surgical suturability, and ability to grasp/adhere to the recipient tissue in the first healing, maintain its integrity and facilitate re-epithelialization of the surgical wound.","definition_or_measurement_approach":"Clinical assessment of suturability and initial adhesion to recipient tissue at first dressing/change, integrity maintenance over follow-up, and facilitation of re-epithelialization of the surgical wound (clinical observation during follow-up visits)."}

Secondary endpoints

• {"endpoint_text":"- Efficacy: Percentage of epithelialization of the lesion 3 weeks after the intervention, time until removal of stitches, time until complete epithelialization. Degree of pain (based on a visual analogue scale and analgesic use data). Aesthetic appearance of the lesion according to the POSAS scale (Van de Kar AL, 2005). Quality of life according to the DLQI indices (Finlay AY, 1994) and the SCI (Rhee JS, 2006; Rhee JS, 2007). Rescue surgeries performed.","definition_or_measurement_approach":"Measures include percentage epithelialization at 3 weeks, time to suture removal, time to complete epithelialization, pain via visual analogue scale and analgesic use, POSAS for scar aesthetics, DLQI and SCI for quality of life, and recording of rescue surgeries."}
• {"endpoint_text":"- Efficacy: Complementarily, a set of structural characteristics, molecular and functional properties of the skin will be measured in the surgical injury using different study techniques: doppler ultrasound, cutaneous homeostasis study, histological tests of skin biopsies using optical microscopy.","definition_or_measurement_approach":"Assessment using doppler ultrasound, cutaneous homeostasis measures (pH, temperature, transepidermal water loss, elasticity), and histological/immunohistochemical analysis of skin biopsies."}
• {"endpoint_text":"- Economic evaluation: A set of variables will be measured with the objective of comparatively analyzing the efficiency of the three types of treatments used in the clinical trial.","definition_or_measurement_approach":"Collection of resource use and cost-related variables to perform comparative economic evaluation between the three treatment types used in the trial."}

Spain

Earliest CTIS Part Ii Submission Date

02-07-2024

Latest Decision Or Authorization Date

05-09-2025

Processing Time Days

430

Number Of Sites

4

Number Of Participants

15

Primary sponsor

Full Name

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

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain