Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Who is this study for? Patients with Basal Cell Carcinoma
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Phase II Clinical Trial Evaluating the Safety and Efficacy of a Tissue Engineered Autologous Skin Substitute Reconstructive Surgery for Basal Cell Carcinoma
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 commmit to use contraceptives of medically proven efficacy.
Locations
Other Locations
Spain
Hospital U. Virgen de las Nieves
RECRUITING
Granada
Hospital U. Virgen de la Victoria
RECRUITING
Málaga
Hospital Costa del Sol
RECRUITING
Marbella
Hospital U. Virgen Macarena
RECRUITING
Seville
Contact Information
Primary
Macarena Guijo Molero
macarena.guijo@juntadeandalucia.es
671 537 264
Time Frame
Start Date: 2022-01-21
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 21
Treatments
Experimental: PHIT
Human artificial skin created by tissue engineering, composed of a sheet of autologous adult differentiated skin keratinocytes and fibroblasts expanded in a biological fibrin-agarose matrix (PHIT).
Experimental: PHITAH
Human artificial skin created by tissue engineering, composed of a sheet of keratinocytes and differentiated autologous adult skin fibroblasts expanded in a biological fibrin-hyaluronic matrix (PHITAH).
Active_comparator: Skin Autograft
Skin autograft.
Related Therapeutic Areas
Sponsors
Leads: Andalusian Network for Design and Translation of Advanced Therapies